FORM 20-F
|
Title of each class
|
Name of each exchange on which registered
|
|
American Depositary Shares, each representing 15
ordinary shares, par value NIS 0.10 per share
|
Nasdaq Capital Market
|
|
Ordinary shares, par value NIS 0.10 per share
|
Nasdaq Capital Market*
|
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
Non-accelerated filer ☒
|
Emerging growth company ☐
|
U.S. GAAP ☐
|
International Financial Reporting Standards as issued by the
International Accounting Standards Board ☒
|
Other ☐
|
Page
|
|
iii
|
|
1 |
|
1 | |
1 | |
1 | |
23
|
|
50 | |
50 | |
59 | |
78 | |
78 | |
78 | |
79 | |
88 |
|
89 |
|
90 |
|
90 |
|
90 |
|
91 |
|
91 |
|
91 |
|
91 |
|
91 |
|
92 |
|
92 |
|
92 |
|
93 |
|
94 |
|
94 |
|
97 |
• |
references to “BioLineRx,” the “Company,” “us,” “we” and “our” refer to BioLineRx Ltd., an Israeli company, and its consolidated subsidiaries;
|
• |
references to “ordinary shares,” “our shares” and similar expressions refer to the Company’s ordinary shares, NIS 0.10 nominal (par) value per share;
|
• |
references to “ADS” or “ADSs” refer to the Company’s American Depositary Shares;
|
• |
references to “dollars,” “U.S. dollars” and “$” are to United States Dollars;
|
• |
references to “shekels” and “NIS” are to New Israeli Shekels, the Israeli currency;
|
• |
references to the “Companies Law” are to Israel’s Companies Law, 5759-1999, as amended; and
|
• |
references to the “SEC” are to the U.S. Securities and Exchange Commission.
|
• |
the initiation, timing, progress and results of our preclinical studies, clinical trials and other therapeutic candidate development efforts;
|
• |
the impact of the COVID-19 pandemic on our operations;
|
• |
our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;
|
• |
our receipt of regulatory approvals for our therapeutic candidates and the timing of other regulatory filings and approvals;
|
• |
the clinical development, commercialization and market acceptance of our therapeutic candidates;
|
• |
our ability to establish and maintain corporate collaborations;
|
• |
our ability to integrate new therapeutic candidates and new personnel;
|
• |
the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in preclinical studies or clinical trials;
|
• |
the implementation of our business model and strategic plans for our business and therapeutic candidates;
|
• |
the scope of protection we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business without infringing the intellectual property rights of others;
|
• |
estimates of our expenses, future revenues, capital requirements and our needs for and ability to access sufficient additional financing;
|
• |
risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere;
|
• |
competitive companies, technologies and our industry; and
|
• |
statements as to the impact of the political and security situation in Israel on our business.
|
Year Ended December 31,
|
||||||||||||||||||||
Consolidated Statements of Operations Data:(1)
|
2016
|
2017
|
2018
|
2019
|
2020
|
|||||||||||||||
(in thousands of U.S. dollars, except share and per share data)
|
||||||||||||||||||||
Research and development expenses
|
(11,177
|
)
|
(19,510
|
)
|
(19,808
|
)
|
(23,438
|
)
|
(18,173
|
)
|
||||||||||
Sales and marketing expenses
|
(1,352
|
)
|
(1,693
|
)
|
(1,362
|
)
|
(857
|
)
|
(840
|
)
|
||||||||||
General and administrative expenses
|
(3,984
|
)
|
(4,037
|
)
|
(4,435
|
)
|
(3,816
|
)
|
(3,914
|
)
|
||||||||||
Operating loss
|
(16,513
|
)
|
(25,240
|
)
|
(25,605
|
)
|
(28,111
|
)
|
(22,927
|
)
|
||||||||||
Non-operating income (expenses), net
|
214
|
(260
|
)
|
2,397
|
4,165
|
(5,701
|
)
|
|||||||||||||
Financial income
|
480
|
1,169
|
719
|
777
|
236
|
|||||||||||||||
Financial expenses
|
(22
|
)
|
(21
|
)
|
(473
|
)
|
(2,277
|
)
|
(1,629
|
)
|
||||||||||
Net loss and comprehensive loss
|
(15,841
|
)
|
(24,352
|
)
|
(22,962
|
)
|
(25,446
|
)
|
(30,021
|
)
|
||||||||||
Net loss per ordinary share
|
(0.28
|
)
|
(0.27
|
)
|
(0.21
|
)
|
(0.17
|
)
|
(0.12
|
)
|
||||||||||
Number of ordinary shares used in computing loss per ordinary share
|
56,144,727
|
89,970,713
|
108,595,702
|
146,407,055
|
252,844,394
|
As of December 31,
|
||||||||||||||||||||
Consolidated Balance Sheet Data:
|
2016
|
2017
|
2018
|
2019
|
2020
|
|||||||||||||||
|
(in thousands of U.S. dollars)
|
|||||||||||||||||||
Cash and cash equivalents
|
2,469
|
5,110
|
3,404
|
5,297
|
16,831
|
|||||||||||||||
Short-term bank deposits
|
33,154
|
44,373
|
26,747
|
22,192
|
5,756
|
|||||||||||||||
Property, plant and equipment, net
|
2,605
|
2,505
|
2,227
|
1,816
|
1,341
|
|||||||||||||||
Total assets
|
38,939
|
60,965
|
56,233
|
53,567
|
47,290
|
|||||||||||||||
Total liabilities
|
3,912
|
8,084
|
14,912
|
20,187
|
25,260
|
|||||||||||||||
Total shareholders’ equity
|
35,027
|
52,881
|
41,321
|
33,380
|
22,030
|
• |
We are a clinical-stage biopharmaceutical development company with a history of operating losses, expect to incur additional losses in the future and may never be profitable;
|
• |
We cannot assure investors that our existing cash and investment balances will be sufficient to meet our future capital requirements.
|
• |
Our business is subject to risks arising from a widespread outbreak of an illness or any other communicable disease, or any other public health crisis, such as the COVID-19 pandemic, which has impacted and
could continue to impact our business.
|
• |
If we or our licensees are unable to obtain U.S. and/or foreign regulatory approval for our therapeutic candidates, we will be unable to commercialize our therapeutic candidates.
|
• |
Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
|
• |
Even if we obtain regulatory approvals, our therapeutic candidates will be subject to ongoing regulatory review and if we fail to comply with continuing U.S. and applicable foreign regulations, we could
lose those approvals and our business would be seriously harmed.
|
• |
We generally depend on out-licensing arrangements for late-stage development, marketing and commercialization of our therapeutic candidates.
|
• |
If we cannot meet requirements under our in-license agreements, we could lose the rights to our therapeutic candidates, which could have a material adverse effect on our business.
|
• |
If we do not meet the requirements under our agreement with the Agalimmune selling shareholders, we could lose the rights to the therapeutic candidates in Agalimmune’s pipeline, including, but not limited
to, AGI-134.
|
• |
We seek to partner with third-party collaborators with respect to the development and commercialization of motixafortide, and we may not succeed in establishing and maintaining collaborative
relationships, which may significantly limit our ability to develop and commercialize our product candidates successfully, if at all.
|
• |
Modifications to our therapeutic candidates, or to any other therapeutic candidates that we may develop in the future, may require new regulatory clearances or approvals or may require us or our licensees,
as applicable, to recall or cease marketing these therapeutic candidates until clearances are obtained.
|
• |
If our competitors develop and market products that are more effective, safer or less expensive than our current or future therapeutic candidates, our prospects will be negatively impacted.
|
• |
We have no experience selling, marketing or distributing products and no internal capability to do so.
|
• |
Our business could suffer if we are unable to attract and retain key employees.
|
• |
Even if our therapeutic candidates receive regulatory approval or do not require regulatory approval, they may not become commercially viable products.
|
• |
Healthcare reforms and related reductions in pharmaceutical pricing, reimbursement and coverage by governmental authorities and third-party payors may adversely affect our business.
|
• |
If third-party payors do not adequately reimburse customers for any of our therapeutic candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not
develop or increase.
|
• |
Our business has a substantial risk of clinical trial and product liability claims. If we are unable to obtain and maintain appropriate levels of insurance, a claim could adversely affect our business.
|
• |
Significant disruptions of our information technology systems or breaches of our data security could adversely affect our business.
|
• |
Our access to most of the intellectual property associated with our therapeutic candidates results from in-license agreements with biotechnology companies and a university, the termination of which would
prevent us from commercializing the associated therapeutic candidates.
|
• |
Patent protection for our products is important and uncertain.
|
• |
If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.
|
• |
Legal proceedings or third-party claims of intellectual property infringement may require us to spend substantial time and money and could prevent us from developing or commercializing products.
|
• |
We may be subject to other patent-related litigation or proceedings that could be costly to defend and uncertain in their outcome.
|
• |
The market prices of our ordinary shares and ADSs are subject to fluctuation, which could result in substantial losses by our investors.
|
• |
Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs.
|
• |
Raising additional capital by issuing securities may cause dilution to existing shareholders.
|
• |
We conduct our operations in Israel and therefore our results may be adversely affected by political, economic and military instability in Israel and its region.
|
• |
Due to a significant portion of our expenses and revenues being denominated in non-dollar currencies, our results of operations may be harmed by currency fluctuations.
|
• |
We have received Israeli government grants and loans for certain research and development expenditures. The terms of these grants and loans may require us to satisfy specified conditions in order to
manufacture products and transfer technologies outside of Israel. We may be required to pay penalties in addition to repayment of the grants and loans.
|
• |
Provisions of Israeli law may delay, prevent or otherwise impede a merger with, or an acquisition of, our company, which could prevent a change of control, even when the terms of such a transaction are
favorable to us and our shareholders.
|
• |
It may be difficult to enforce a U.S. judgment against us and our officers and directors in Israel or the United States, or to serve process on our officers and directors.
|
• |
Your rights and responsibilities as a shareholder will be governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. companies.
|
• |
a therapeutic candidate or medical device may not prove safe or efficacious;
|
• |
the results with respect to any therapeutic candidate may not confirm the positive results from earlier preclinical studies or clinical trials;
|
• |
the results may not meet the level of statistical significance required by the U.S. Food and Drug Administration, or FDA, or other regulatory authorities; and
|
• |
the results will justify only limited and/or restrictive uses, including the inclusion of warnings and contraindications, which could significantly limit the marketability and profitability of the
therapeutic candidate.
|
• |
delays in securing clinical investigators or trial sites for the clinical trials;
|
• |
delays in obtaining institutional review board and other regulatory approvals to commence a clinical trial;
|
• |
slower-than-anticipated patient recruitment and enrollment;
|
• |
negative or inconclusive results from clinical trials;
|
• |
unforeseen safety issues;
|
• |
uncertain dosing issues;
|
• |
an inability to monitor patients adequately during or after treatment; and
|
• |
problems with investigator or patient compliance with the trial protocols.
|
• |
restrictions on such product, manufacturer or manufacturing process;
|
• |
warning letters from the FDA or other regulatory authorities;
|
• |
withdrawal of the product from the market;
|
• |
suspension or withdrawal of regulatory approvals;
|
• |
refusal to approve pending applications or supplements to approved applications that we or our licensees submit;
|
• |
voluntary or mandatory recall;
|
• |
fines;
|
• |
refusal to permit the import or export of our products;
|
• |
product seizure or detentions;
|
• |
injunctions or the imposition of civil or criminal penalties; or
|
• |
adverse publicity.
|
• |
we have limited control over the amount and timing of resources that our licensees devote to our therapeutic candidates;
|
• |
our licensees may experience financial difficulties;
|
• |
our licensees may fail to secure adequate commercial supplies of our therapeutic candidates upon marketing approval, if at all;
|
• |
our future revenues depend heavily on the efforts of our licensees;
|
• |
business combinations or significant changes in a licensee’s business strategy may adversely affect the licensee’s willingness or ability to complete its obligations under any arrangement with us;
|
• |
a licensee could move forward with a competing therapeutic candidate developed either independently or in collaboration with others, including our competitors; and
|
• |
out-licensing arrangements are often terminated or allowed to expire, which would delay the development and may increase the development costs of our therapeutic candidates.
|
● |
a collaboration partner may shift its priorities and resources away from our therapeutic candidates due to a change in business strategies, or a merger, acquisition, sale or downsizing;
|
● |
a collaboration partner may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons;
|
● |
a collaboration partner may cease development in therapeutic areas which are the subject of our strategic collaboration;
|
● |
a collaboration partner may not devote sufficient capital or resources towards our therapeutic candidates;
|
● |
a collaboration partner may change the success criteria for a therapeutic candidate thereby delaying or ceasing development of such candidate;
|
● |
a significant delay in initiation of certain development activities by a collaboration partner will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities;
|
● |
a collaboration partner could develop a product that competes, either directly or indirectly, with our therapeutic candidate;
|
● |
a collaboration partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product;
|
● |
a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements;
|
● |
a partner may exercise a contractual right to terminate a strategic alliance;
|
● |
a dispute may arise between us and a partner concerning the research, development or commercialization of a therapeutic candidate resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting
in costly litigation or arbitration which may divert management attention and resources; and
|
● |
a partner may use our products or technology in such a way as to invite litigation from a third party.
|
• |
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
|
• |
the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our therapeutic candidates;
|
• |
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
• |
unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization.
|
• |
reliance on the third party for regulatory compliance and quality assurance;
|
• |
limitations on supply availability resulting from capacity and scheduling constraints of the third parties;
|
• |
impact on our reputation in the marketplace if manufacturers of our products, once commercialized, fail to meet customer demands;
|
• |
the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and
|
• |
the possible termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.
|
• |
difficulty in large-scale manufacturing;
|
• |
low market acceptance by physicians, healthcare payors, patients and the medical community as a result of lower demonstrated clinical safety or efficacy compared to other products, prevalence and severity
of adverse side effects, or other potential disadvantages relative to alternative treatment methods;
|
• |
insufficient or unfavorable levels of reimbursement from government or third-party payors;
|
• |
infringement on proprietary rights of others for which we or our licensees have not received licenses;
|
• |
incompatibility with other therapeutic products;
|
• |
other potential advantages of alternative treatment methods;
|
• |
ineffective marketing and distribution support;
|
• |
significant changes in pricing due to pressure from public opinion, non-governmental organizations or governmental authorities;
|
• |
lack of cost-effectiveness; or
|
• |
timing of market introduction of competitive products.
|
• |
a covered benefit under its health plan;
|
• |
safe, effective and medically necessary;
|
• |
appropriate for the specific patient;
|
• |
cost-effective; and
|
• |
neither experimental nor investigational.
|
• |
announcements of technological innovations or new products by us or others;
|
• |
announcements by us of significant acquisitions, strategic partnerships, in-licensing, out-licensing, joint ventures or capital commitments;
|
• |
expiration or terminations of licenses, research contracts or other collaboration agreements;
|
• |
public concern as to the safety of drugs we, our licensees or others develop;
|
• |
general market conditions;
|
• |
the volatility of market prices for shares of biotechnology companies generally;
|
• |
success of research and development projects;
|
• |
departure of key personnel;
|
• |
developments concerning intellectual property rights or regulatory approvals;
|
• |
variations in our and our competitors’ results of operations;
|
• |
changes in earnings estimates or recommendations by securities analysts, if our ordinary shares or ADSs are covered by analysts;
|
• |
statements about the Company made in the financial media or by bloggers on the Internet;
|
• |
statements made about drug pricing and other industry-related issues by government officials;
|
• |
changes in government regulations or patent decisions;
|
• |
developments by our licensees; and
|
• |
general market conditions and other factors, including factors unrelated to our operating performance.
|
• |
the failure to obtain regulatory approval or achieve commercial success of our therapeutic candidates;
|
• |
our success in effecting out-licensing arrangements with third parties;
|
• |
our success in establishing other out-licensing or co-development arrangements;
|
• |
the success of our licensees in selling products that utilize our technologies;
|
• |
the results of our preclinical studies and clinical trials for our earlier stage therapeutic candidates, and any decisions to initiate clinical trials if supported by the preclinical results;
|
• |
the costs, timing and outcome of regulatory review of our therapeutic candidates that progress to clinical trials;
|
• |
the costs of establishing or acquiring specialty sales, marketing and distribution capabilities, if any of our therapeutic candidates are approved, and we decide to commercialize them ourselves;
|
• |
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our issued patents and defending intellectual property-related claims;
|
• |
the extent to which we acquire or invest in businesses, products or technologies and other strategic relationships; and
|
• |
the costs of financing unanticipated working capital requirements and responding to competitive pressures.
|
• |
Revenue sharing payments. These are payments to be made to licensors with respect to revenue we receive from sub-licensing to third parties for further development
and commercialization of our drug products. These payments are generally fixed at a percentage of the total revenues we earn from these sublicenses.
|
• |
Milestone payments. These payments are generally linked to the successful achievement of milestones in the development and approval of drugs, such Phases 1, 2 and 3
of clinical trials and approvals of NDAs.
|
• |
Royalty payments. To the extent we elect to complete the development, licensing and marketing of a therapeutic candidate, we are generally required to pay our
licensors royalties on the sales of the end drug product. These royalty payments are generally based on the net revenue from these sales. In certain instances, the rate of the royalty payments decreases upon the expiration of the drug’s
underlying patent and its transition into a generic drug. Certain of our agreements provide that if a licensed drug product is developed and sold through a different corporate entity, the licensors may elect to receive shares in such
company instead of a portion of the royalties.
|
• |
Additional payments. In addition to the above payments, certain of our in-license agreements provide for a one-time or periodic payment that is not linked to
milestones. Periodic payments may be paid until the commercialization of the product, either by direct sales or sublicenses to third parties. Other agreements provide for the continuation of these payments even following the
commercialization of the licensed drug product.
|
• |
The motixafortide drug product candidate is covered as a composition of matter by a provisional patent application. Corresponding patents, if granted, will expire in December 2041, not
including any applicable patent term extension, which may add an additional term of up to five years on the patent. We also have an exclusive license to a patent family that covers the active ingredient molecule per se. Patents of this
family have been granted in the U.S., Europe, Japan and Canada. The patents will expire in August 2023, not including any applicable patent term extension. We have an exclusive license to a patent family that covers motixafortide combined
with a PD1 antagonist for the treatment of cancer. A patent of this family has been granted in the U.S., and member patent applications are pending in Europe, Japan, China, Canada, Australia, India, Korea, Mexico, Brazil and Israel. The
granted U.S. patent and patents to issue in the future based on pending patent applications in this family will expire in 2036, not including any applicable patent term extension. In addition, we have an exclusive license to nineteen
other patent families pending or granted worldwide directed to methods of synthesis of motixafortide and methods of use of motixafortide either alone or in combination with other drugs for the treatment of certain types of cancer and
other indications. Furthermore, we have Orphan Drug status for AML, pancreatic cancer and stem cell mobilization, as well as data exclusivity protection afforded to motixafortide as an NCE.
|
• |
With respect to AGI-134, Agalimmune owns or has an exclusive license to three patent families that cover the AGI-134 compound and its use for treating cancer. The use of AGI-134 for treating solid tumors is
covered by patents granted in the U.S., Europe, China, Japan and other countries. The patents will expire in 2035, not including any applicable patent term extensions. The compound AGI-134 is covered by patents granted in the United
States, Europe, Japan and other countries. The patents will expire in 2025, not including any applicable patent term extensions. In addition, the future drug product is eligible for obtaining regulatory Biological Product exclusivity (12
years of market exclusivity in the U.S.).
|
• |
With respect to BL-5010, we have an exclusive license to a patent family directed to a novel applicator uniquely configured for applying the BL-5010 composition to targeted skin tissue safely and
effectively. Patents in this family have been granted in the U.S., Europe, Israel, Japan and China. The patents will expire in 2034.
|
• |
preclinical laboratory tests, animal studies and formulation development;
|
• |
submission to the FDA of an Investigational New Drug, or IND, application to conduct human clinical testing;
|
• |
adequate and well controlled clinical trials to determine the safety and efficacy of the drug for each indication as well as to establish the exposure levels;
|
• |
submission to the FDA of an application for marketing approval;
|
• |
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is manufactured; and
|
• |
FDA review and approval of the drug for marketing.
|
• |
Consistent rules for conducting clinical trials throughout the EU; and
|
• |
Publicly available information on the authorization, conduct and results of each clinical trial carried out in the EU
|
o |
Harmonized electronic submission and assessment process for clinical trials conducted in multiple member states;
|
o |
Improved collaboration, information sharing and decision-making between and within member states;
|
o |
Increased transparency of information on clinical trials;
|
o |
Higher standards of safety for all participants in EU clinical trials.
|
Project
|
Status
|
Expected Near Term Milestones
|
||
motixafortide
|
1. |
Phase 3 registration study in autologous stem cell mobilization (GENESIS) ongoing, positive results from interim analysis announced October 2020; as recommended by DMC, study enrollment
was completed at 122 patients
|
1. |
a. Top-line results for the study expected in early second quarter of 2021
b. Pre-NDA meeting with FDA in second half of 2021
c. NDA submission in first half of 2022
|
2. |
Phase 2a study in pancreatic cancer (COMBAT/KEYNOTE-202) completed; full results showing improvement in all endpoints announced December 2020
|
2. |
Evaluation and planning of next clinical development steps, including discussions towards potential collaborations
|
|
3. |
Phase 2a study for relapsed or refractory AML completed
|
3. |
Follow-up for overall survival is ongoing; evaluation and decision regarding next clinical development steps
|
|
4. |
Phase 2 investigator-initiated study in first-line PDAC patients
|
4. |
Data from the study is anticipated in mid-2022*
|
|
5. |
Phase 1b study in patients with ARDS secondary to COVID-19 and other respiratory viral infections
|
5. |
Results of the preliminary analysis are expected in the second half of 2021*
|
|
AGI-134
|
Phase 1/2a study, ongoing
|
Initial proof-of-mechanism efficacy results of part 2 of study expected in second half of 2021
|
• |
the number of sites included in the clinical trials;
|
• |
the length of time required to enroll suitable patients;
|
• |
the cost of drug substance/product manufacturing, storage and shipment;
|
• |
the number of patients that participate in the clinical trials;
|
• |
the duration of patient follow-up;
|
• |
whether the patients require hospitalization or can be treated on an out-patient basis;
|
• |
the development stage of the therapeutic candidate; and
|
• |
the efficacy and safety profile of the therapeutic candidate.
|
• |
identify the contract with a customer;
|
• |
identify the performance obligations in the contract;
|
• |
determine the transaction price;
|
• |
allocate the transaction price to the performance obligations in the contract; and
|
• |
recognize revenue when (or as) the entity satisfies a performance obligation.
|
Three Months Ended
|
||||||||||||||||||||||||||||||||
March 31
|
June 30
|
Sept. 30
|
Dec. 31
|
March 31
|
June 30
|
Sept. 30
|
Dec. 31
|
|||||||||||||||||||||||||
2019
|
2020
|
|||||||||||||||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||||||||||
Consolidated Statements of Operations
|
||||||||||||||||||||||||||||||||
Revenues
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
||||||||||||||||||||||||
Cost of revenues
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
||||||||||||||||||||||||
Research and development expenses
|
(4,392
|
) |
(5,302
|
) |
(5,558
|
) |
(8,186
|
) |
(5,422
|
)
|
(4,640
|
)
|
(3,484
|
)
|
(4,627
|
)
|
||||||||||||||||
Sales and marketing expenses
|
(256
|
) |
(226
|
) |
(201
|
) |
(174
|
) |
(175
|
)
|
(182
|
)
|
(309
|
)
|
(174
|
)
|
||||||||||||||||
General and administrative expenses
|
(930
|
) |
(949
|
) |
(884
|
) |
(1,053
|
) |
(1,243
|
)
|
(744
|
)
|
(856
|
)
|
(1,071
|
)
|
||||||||||||||||
Operating loss
|
(5,578
|
) |
(6,477
|
) |
(6,643
|
) |
(9,413
|
) |
(6,840
|
)
|
(5,566
|
)
|
(4,649
|
)
|
(5,872
|
)
|
||||||||||||||||
Non-operating income (expenses), net
|
(340
|
) |
1,261
|
3,055
|
189
|
469
|
(843
|
)
|
294
|
(5,621
|
)
|
|||||||||||||||||||||
Financial income
|
210
|
171
|
247
|
149
|
140
|
35
|
39
|
22
|
||||||||||||||||||||||||
Financial expenses
|
(447
|
) |
(440
|
)
|
(597
|
) |
(793
|
) |
(414
|
)
|
(396
|
)
|
(302
|
)
|
(517
|
)
|
||||||||||||||||
Net loss
|
(6,155
|
) |
(5,485
|
) |
(3,938
|
) |
(9,868
|
) |
(6,645
|
)
|
(6,770
|
)
|
(4,618
|
)
|
(11,988
|
)
|
• |
the progress and costs of our preclinical studies, clinical trials and other research and development activities;
|
• |
the impact of the COVID-19 pandemic on our operations;
|
• |
the scope, prioritization and number of our clinical trials and other research and development programs;
|
• |
the amount of revenues we receive under our collaboration or licensing arrangements;
|
• |
the costs of the development and expansion of our operational infrastructure;
|
• |
the costs and timing of obtaining regulatory approval of our therapeutic candidates;
|
• |
the ability of our collaborators to achieve development milestones, marketing approval and other events or developments under our collaboration agreements;
|
• |
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
|
• |
the costs and timing of securing manufacturing arrangements for clinical or commercial production;
|
• |
the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us;
|
• |
the costs of acquiring or undertaking development and commercialization efforts for any future product candidates;
|
• |
the magnitude of our general and administrative expenses;
|
• |
interest and principal payments on the loan from Kreos Capital;
|
• |
any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates;
|
• |
market conditions; and
|
• |
payments to the IIA.
|
|
Total
|
Less than
1 year |
1-3 years
|
4-5 years
|
More than
5 years |
|||||||||||||||
|
(in thousands of U.S. dollars)
|
|||||||||||||||||||
|
||||||||||||||||||||
Car leasing obligations
|
127
|
105
|
22
|
-
|
-
|
|||||||||||||||
Premises leasing obligations
|
1,998
|
444
|
844
|
666
|
-
|
|||||||||||||||
Purchase commitments
|
6,891
|
6,580
|
291
|
20
|
-
|
|||||||||||||||
Total
|
9,016
|
7,129
|
1,157
|
668
|
-
|
Name
|
|
Age
|
|
Position(s)
|
|
|
|
|
|
Philip A. Serlin, CPA, MBA
|
|
60
|
|
Chief Executive Officer
|
|
|
|
|
|
Mali Zeevi, CPA
|
|
45
|
|
Chief Financial Officer
|
|
|
|
|
|
Ella Sorani, Ph.D.
|
|
53
|
|
Chief Development Officer
|
|
|
|
|
|
Abi Vainstein-Haras, M.D.
|
|
46
|
|
Chief Medical Officer
|
|
|
|
|
|
Aharon Schwartz, Ph.D. (1)
|
|
78
|
|
Chairman of the Board
|
|
|
|
|
|
Michael J. Anghel, Ph.D. (1)(4)
|
|
82
|
|
Director
|
|
|
|
|
|
Nurit Benjamini, MBA (1)(2)(3)(4)
|
|
54
|
|
External Director
|
|
|
|
|
|
B.J. Bormann, Ph.D. (1)
|
|
62
|
|
Director
|
|
|
|
|
|
Raphael Hofstein, Ph.D. (1)(2)(3)
|
|
71
|
|
Director
|
|
|
|
|
|
Avraham Molcho, M.D. (1)(2)(3)
|
|
63
|
|
External Director
|
|
|
|
|
|
Sandra Panem, Ph.D. (1)
|
|
74
|
|
Director
|
(1) |
Independent director under applicable Nasdaq Capital Market and SEC rules, as affirmatively determined by our Board.
|
(2) |
A member of our audit committee.
|
(3) |
A member of our compensation committee.
|
(4) |
A member of our investment monitoring committee.
|
|
Salaries, fees, commissions and bonuses
|
Pension, retirement, options and other similar benefits
|
||||||
|
(in thousands of U.S. dollars)
|
|||||||
All directors and senior management as a group, consisting of [11] persons
|
1,505
|
1,259
|
Name and Position
|
Salary
|
Social Benefits(1)
|
Bonuses
|
Value of Options Granted(2)
|
All Other
Compensation(3)
|
Total
|
||||||||||||||||||
|
(in thousands of U.S. dollars)
|
|||||||||||||||||||||||
Philip A. Serlin
Chief Executive Officer
|
250
|
86
|
198
|
403
|
21
|
958
|
||||||||||||||||||
Mali Zeevi
Chief Financial Officer
|
154
|
45
|
98
|
136
|
17
|
450
|
||||||||||||||||||
Abi Vainstein-Haras
Chief Medical Officer
|
176
|
52
|
100
|
140
|
19
|
487
|
||||||||||||||||||
Ella Sorani
Chief Development Officer
|
182
|
55
|
102
|
140
|
18
|
497
|
• |
the majority of the shares that are voted at the meeting, including at least a majority of the shares held by non-controlling shareholders or shareholders who do not have a personal interest in the election
of the external director (other than a personal interest not deriving from a relationship with a controlling shareholder) who voted at the meeting, excluding abstentions, vote in favor of the election of the external director; or
|
• |
the total number of shares held by non-controlling, disinterested shareholders (as described in the preceding bullet point) that are voted against the election of the external director does not exceed 2% of
the aggregate voting rights in the company.
|
• |
an employment relationship;
|
• |
a business or professional relationship even if not maintained on a regular basis (excluding insignificant relationships);
|
• |
control; and
|
• |
service as an office holder, excluding service as a director in a private company prior to the first offering of its shares to the public if such director was appointed as a director of the private company
in order to serve as an external director following the public offering.
|
• |
the chairman of the company’s board of directors;
|
• |
a controlling shareholder or a relative of a controlling shareholder of the company (as each such term is defined in the Companies Law); or
|
• |
any director employed by the company, by a controlling shareholder of the company or by any other entity controlled by a controlling shareholder of the company, or any director who provides services to the
company, to a controlling shareholder of the company or to any other entity controlled by a controlling shareholder of the company on a regular basis (other than as a member of the board of directors), or any other director whose main
source of income derives from a controlling shareholder of the company.
|
• |
he or she meets the qualifications for being appointed as an external director, except for (i) the requirement that the director be an Israeli resident (which does not apply to companies such as ours whose
securities have been offered outside of Israel or are listed outside of Israel) and (ii) the requirement for accounting and financial expertise or professional qualifications; and
|
• |
he or she has not served as a director of the company for a period exceeding nine consecutive years. For this purpose, a break of less than two years in the service shall not be deemed to interrupt the
continuation of the service.
|
• |
oversight of the company’s independent registered public accounting firm and recommending the engagement, compensation or termination of engagement of our independent registered public accounting firm to
our Board of Directors in accordance with Israeli law;
|
• |
recommending the engagement or termination of the office of our internal auditor; and
|
• |
reviewing and pre-approving the terms of audit and non-audit services provided by our independent auditors.
|
• |
the chairman of the company’s board of directors;
|
• |
a controlling shareholder or a relative of a controlling shareholder of the company (as each such term is defined in the Companies Law); or
|
• |
any director employed by the company, by a controlling shareholder of the company or by any other entity controlled by a controlling shareholder of the company, or any director who provides services to the
company on a permanent basis, to a controlling shareholder of the company or to any other entity controlled by a controlling shareholder of the company on a regular basis (other than as a member of the board of directors), or any other
director whose main source of income derives from a controlling shareholder of the company.
|
• |
to make recommendations to the board of directors as to a compensation policy for officers, as well as to recommend once every three years to extend the compensation policy, subject to receipt of the
required corporate approvals;
|
• |
to make recommendations to the board of directors as to any updates to the compensation policy which may be required;
|
• |
to review the implementation of the compensation policy by the company;
|
• |
to approve transactions relating to terms of office and employment of certain company office holders, that require the approval of the compensation committee pursuant to the Companies Law; and
|
• |
to exempt, under certain circumstances, a transaction relating to terms of office and employment from the requirement of approval of the shareholders meeting.
|
(i) |
the majority of the votes includes at least a majority of all the votes of shareholders who are not controlling shareholders of the company or who do not have a personal interest in the compensation policy and participating in the
vote; abstentions shall not be included in the total of the votes of the aforesaid shareholders; or
|
(ii) |
the total of opposing votes from among the shareholders described in subsection (i) above does not exceed 2% of all the voting rights in the company.
|
• |
a person (or a relative of a person) who holds more than 5% of the company’s shares;
|
• |
a person (or a relative of a person) who has the power to appoint a director or the general manager of the company;
|
• |
an executive officer or director of the company; or
|
• |
a member of the company’s independent accounting firm.
|
• |
information on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and
|
• |
all other important information pertaining to these actions.
|
• |
The duty of loyalty requires an office holder to act in good faith and for the benefit of the company, and includes the duty to:
|
• |
refrain from any act involving a conflict of interest between the performance of his or her duties in the company and his or her other duties or personal affairs;
|
• |
refrain from any activity that is competitive with the business of the company;
|
• |
refrain from exploiting any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself or others; and
|
• |
disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder.
|
• |
a transaction other than in the ordinary course of business;
|
• |
a transaction that is not on market terms; or
|
• |
a transaction that may have a material impact on the company’s profitability, assets or liabilities.
|
• |
A transaction with an office holder in a public company that is neither a director nor the chief executive officer regarding his or her terms of office and employment requires approval by the (i)
compensation committee; and (ii) the board of directors. Approval of terms of office and employment for such officers which do not comply with the compensation policy may nonetheless be approved subject to two cumulative conditions: (i)
the compensation committee and thereafter the board of directors, approved the terms after having taken into account the various considerations and mandatory requirements set forth in the Companies Law with respect to office holder
compensation, and (ii) the shareholders of the company have approved the terms by means of the following special majority requirements, or the Special Majority Requirements, as set forth in the Companies Law, pursuant to which the
shareholder approval must either include at least one-half of the shares held by non-controlling and disinterested shareholders who actively participate in the voting process (without taking abstaining votes into account), or,
alternatively, the total shareholdings of the non-controlling and disinterested shareholders who vote against the transaction must not represent more than 2% of the voting rights in the company. However, the transaction may still be
approved despite shareholder rejection, provided that a company’s compensation committee and thereafter the board of directors have determined to approve the proposal, based on detailed reasoning, after having re-examined the terms of
office and employment, and taken the shareholder rejection into consideration.
|
• |
A transaction with the chief executive officer in a public company regarding his or her terms of office and employment requires approval by the (i) compensation committee; (ii) the board of directors; and
(iii) the shareholders of the company by the Special Majority Requirements. Approval of terms of office and employment for the chief executive officer which do not comply with the compensation policy may nonetheless be approved subject to
two cumulative conditions: (i) the compensation committee and thereafter the board of directors, approved the terms after having taken into account the various considerations and mandatory requirements set forth in the Companies Law with
respect to office holder compensation and (ii) the shareholders of the company have approved the terms by means of the Special Majority Requirements, as detailed above. However, a transaction with a chief executive officer that is not
approved by shareholders may still be approved despite shareholder rejection, provided that a company’s compensation committee and thereafter the board of directors have determined to approve the proposal, based on detailed reasoning,
after having re-examined the terms of office and employment, and taken the shareholder rejection into consideration. In addition, the compensation committee may exempt the transaction regarding terms of office and employment with a
candidate for the office of chief executive officer where such officer has no relationship with the controlling shareholder or the company from shareholder approval if it has found, based on detailed reasons, that bringing the transaction
to the approval of the shareholders meeting shall prevent the employment of such candidate by the company. Such approval may be given only in respect of terms of office and employment which are in accordance with the company’s
compensation policy.
|
• |
A transaction with a director who is not the chief executive officer of a public company regarding his or her terms of office and engagement requires approval by the (i) compensation committee; (ii) the
board of directors; and (iii) the shareholders of the company. Approval of terms of office and employment for directors of a company which do not comply with the compensation policy may nonetheless be approved subject to two cumulative
conditions: (i) the compensation committee and thereafter the board of directors, approved the terms after having taken into account the various considerations and mandatory requirements set forth in the Companies Law with respect to
office holder compensation and (ii) the shareholders of the company have approved the terms by means of the Special Majority Requirements, as detailed above. In addition, pursuant to a relief provided under the Companies Regulations
(Relief in Interested Party Transactions), 2000, the compensation committee may exempt the transaction regarding terms of office and engagement with a non-executive director, if the compensation committee and board of directors determined
that such terms of office are only for the benefit of the company, or if the compensation terms of the director do not exceed the maximum compensation paid to external directors pursuant to the applicable regulations.
|
• |
at least a majority of the shares held by shareholders who have no personal interest in the transaction and are voting at the meeting must be voted in favor of approving the transaction, excluding
abstentions; or
|
• |
the shares voted by shareholders who have no personal interest in the transaction who vote against the transaction represent no more than 2% of the voting rights in the company.
|
• |
an amendment to the articles of association;
|
• |
an increase in the company’s authorized share capital;
|
• |
a merger; and
|
• |
the approval of related party transactions and acts of office holders that require shareholder approval.
|
• |
financial liability imposed on him or her in favor of another person pursuant to a judgment, settlement or arbitrator’s award approved by a court. However, if an undertaking to indemnify an office holder
with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify
is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned events and amount or criteria;
|
• |
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or
proceeding, provided that (1) no indictment was filed against such office holder as a result of such investigation or proceeding; and (2) no financial liability, such as a criminal penalty, was imposed upon him or her as a substitute for
the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal intent; and
|
• |
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf or by a third party
or in connection with criminal proceedings in which the office holder was acquitted or as a result of a conviction for an offense that does not require proof of criminal intent.
|
• |
a breach of duty of loyalty to the company, to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company;
|
• |
a breach of duty of care to the company or to a third party, including a breach arising out of the negligent (but not grossly negligent) conduct of the office holder; and
|
• |
a financial liability imposed on the office holder in favor of a third party.
|
• |
a breach of duty of loyalty, except to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company;
|
• |
a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;
|
• |
an act or omission committed with intent to derive illegal personal benefit; or
|
• |
a fine or forfeit levied against the office holder.
|
|
December 31,
|
|||||||||||
|
2018
|
2019
|
2020
|
|||||||||
|
||||||||||||
Management and administration
|
10
|
10
|
9
|
|||||||||
Research and development
|
34
|
30
|
27
|
|||||||||
Sales and marketing
|
4
|
2
|
2
|
|||||||||
Total
|
48
|
42
|
38
|
|
Number of
|
|||||||
|
Ordinary Shares
|
|||||||
|
Beneficially
|
Percent of
|
||||||
|
Held
|
Class
|
||||||
|
||||||||
Directors
|
||||||||
|
||||||||
Aharon Schwartz(1)
|
2,011,666
|
*
|
||||||
Michael J. Anghel(2)
|
256,666
|
*
|
||||||
Nurit Benjamini(3)
|
236,666
|
*
|
||||||
B.J. Bormann(4)
|
256,666
|
*
|
||||||
Raphael Hofstein(5)
|
256,666
|
*
|
||||||
Avraham Molcho(6)
|
236,666
|
*
|
||||||
Sandra Panem(7)
|
269,166
|
*
|
||||||
|
||||||||
Executive officers
|
||||||||
|
||||||||
Philip A. Serlin(8)
|
2,436,817
|
*
|
||||||
Mali Zeevi(9)
|
1,019,687
|
*
|
||||||
Ella Sorani(10)
|
812,842
|
*
|
||||||
Abi Vainstein-Haras(11)
|
1,006,917
|
*
|
||||||
All directors and executive officers as a group (11 persons)(12)
|
8,800,425
|
1.38
|
% |
*
|
Less than 1.0%.
|
|
|
(1)
|
Includes 256,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334 ordinary shares issuable upon exercise of outstanding options that
are not exercisable within 60 days of February 22, 2021.
|
|
|
(2)
|
Includes 256,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334 ordinary shares issuable upon exercise of outstanding options that
are not exercisable within 60 days of February 22, 2021.
|
|
|
(3)
|
Includes 236,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334 ordinary shares issuable upon exercise of outstanding options that
are not exercisable within 60 days of February 22, 2021.
|
|
|
(4)
|
Includes 256,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334 ordinary shares issuable upon exercise of outstanding options that
are not exercisable within 60 days of February 22, 2021.
|
|
|
(5)
|
Includes 256,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334 ordinary shares issuable upon exercise of outstanding options that
are not exercisable within 60 days of February 22, 2021.
|
|
|
(6)
|
Includes 236,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334 ordinary shares issuable upon exercise of outstanding options that
are not exercisable within 60 days of February 22, 2021.
|
|
|
(7)
|
Includes 269,166 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334 ordinary shares issuable upon exercise of outstanding options that
are not exercisable within 60 days of February 22, 2021.
|
|
|
(8)
|
Includes 2,264,899 issued ordinary shares upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 1,180,657 ordinary shares issuable upon exercise of outstanding equity
instruments that are not exercisable within 60 days of February 22, 2021.
|
|
|
(9)
|
Includes 942,337 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 1,631,733 ordinary shares issuable upon exercise of outstanding equity
instruments that are not exercisable within 60 days of February 22, 2021.
|
|
|
(10)
|
Includes 746,692 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 1,636,658 ordinary shares issuable upon exercise of outstanding equity
instruments that are not exercisable within 60 days of February 22, 2021.
|
|
|
(11)
|
Includes 924,167 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 1,649,783 ordinary shares issuable upon exercise of outstanding equity
instruments that are not exercisable within 60 days of February 22, 2021.
|
|
|
(12)
|
Includes 6,647,257 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 7,032,169 ordinary shares issuable upon exercise of outstanding equity
instruments that are not exercisable within 60 days of February 22, 2021.
|
• |
the excess distribution or gain would be allocated ratably over the Non-Electing U.S. Investor’s holding period for the ordinary shares or ADSs;
|
• |
the amount allocated to the current taxable year and any year prior to us becoming a PFIC would be taxed as ordinary income; and
|
• |
the amount allocated to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer for that year, and an interest charge for the deemed
deferral benefit would be imposed with respect to the resulting tax attributable to each such other taxable year.
|
• |
taxes and other governmental charges;
|
• |
any applicable transfer or registration fees;
|
• |
certain cable, telex and facsimile transmission charges as provided in the deposit agreement;
|
• |
any expenses incurred in the conversion of foreign currency;
|
• |
a fee of $5.00 or less per 100 ADSs (or a portion thereof) for the execution and delivery of ADRs and the surrender of ADRs, including if the deposit agreement terminates;
|
• |
a fee of $.05 or less per ADS (or portion thereof) for any cash distribution made pursuant to the deposit agreement;
|
• |
a fee for the distribution of securities pursuant to the deposit agreement;
|
• |
in addition to any fee charged for a cash distribution, a fee of $.05 or less per ADS (or portion thereof) per annum for depositary services;
|
• |
a fee for the distribution of proceeds of rights that the Depositary sells pursuant to the deposit agreement; and
|
• |
any other charges payable by the Depositary, any of the Depositary’s agents, or the agents of the Depositary’s agents in connection with the servicing of ordinary shares or other Deposited Securities.
|
|
Year Ended December 31,
|
|||||||
|
2019
|
2020
|
||||||
Services Rendered
|
(in thousands of U.S. dollars)
|
|||||||
|
||||||||
Audit Fees(1)
|
110
|
110
|
||||||
Audit-Related Fees(2)
|
10
|
38
|
||||||
Tax Fees(3)
|
9
|
16
|
||||||
All Other Fees
|
-
|
-
|
||||||
Total
|
129
|
164
|
• |
Distribution of annual and quarterly reports to shareholders. Under Israeli law, as a public company whose shares are traded on the TASE, we are not required to
distribute annual and quarterly reports directly to shareholders and the generally accepted business practice in Israel is not to distribute such reports to shareholders but to make such reports publicly available through the website of
the ISA and the TASE. In addition, we make our audited financial statements available to our shareholders at our offices. As a foreign private issuer, we are generally exempt from the SEC’s proxy solicitation rules.
|
• |
Quorum. While the Nasdaq Rules require that the quorum for purposes of any meeting of the holders of a listed company’s common voting stock, as specified in the
company’s bylaws, be no less than 33 1/3% of the company’s outstanding common voting stock, under Israeli law, a company is entitled to determine in its articles of association the number of shareholders and percentage of holdings
required for a quorum at a shareholders meeting. Our Articles of Association provide that a quorum of two or more shareholders holding at least 25% of the voting rights in person or by proxy is required for commencement of business at a
general meeting. However, the quorum set forth in our Articles of Association with respect to an adjourned meeting consists of any number of shareholders present in person or by proxy.
|
• |
Independent Directors. Our Board of Directors includes two external directors in accordance with the provisions contained in Sections 239-249 of the Companies Law
and Rule 10A-3 of the general rules and regulations promulgated under the Securities Act, rather than a majority of external directors. Israeli law does not require, nor do our independent directors conduct, regularly scheduled meetings
at which only they are present. We are required, however, to ensure that all members of our Audit Committee are “independent” under the applicable Nasdaq and SEC criteria for independence (as a foreign private issuer we are not exempt
from the SEC independence requirement), and we must also ensure that a majority of the members of our Audit Committee are independent directors as defined in the Companies Law. Furthermore, Israeli law does not require, nor do our
independent directors conduct, regularly scheduled meetings at which only they are present, which the Nasdaq Rules otherwise require. If we qualify as an Eligible Company and opt to follow the exemption provided under the Relief
Regulations regarding appointment of external directors and composition of the audit and compensation committees, we will be required at all times to comply with the U.S. rules and regulations governing the appointment of independent
directors and composition of the audit and compensation committees applicable to U.S. domestic issuers instead of complying with the Companies Law provisions relating to external directors and composition of the audit and compensation
committees.
|
• |
Audit Committee. Our Audit Committee complies with all of the requirements under Israeli law, and is composed of two external directors, which are all of our
external directors, and only one other director, who cannot be the chairman of our Board of Directors. Consistent with Israeli law, the independent auditors are elected at a meeting of shareholders instead of being appointed by the Audit
Committee. If we qualify as an Eligible Company and opt to follow the exemption provided under the Relief Regulations regarding appointment of external directors and composition of the audit and compensation committees, we will be
required at all times to comply with the U.S. rules and regulations governing the appointment of independent directors and composition of the Audit Committee applicable to U.S. domestic issuers instead of complying with the Companies Law
provisions relating to external directors and composition of the Audit Committee.
|
• |
Nomination of our Directors. With the exception of our external directors and directors elected by our Board of Directors due to vacancy, our directors are elected
by a general or extraordinary meeting of our shareholders, to hold office until they are removed from office by the majority of our shareholders at a general or extraordinary meeting of our shareholders. See “Item 6. Directors, Senior
Management and Employees — Board Practices — Board of Directors.” The nominations for directors, which are presented to our shareholders, are generally made by our directors, but nominations may be made by one or more of our shareholders
as provided under the Companies Law or in an agreement between us and our shareholders. Currently, there is no agreement between us and any shareholder regarding the nomination of directors. In accordance with our Articles of Association,
under the Companies Law, any one or more shareholders holding, in the aggregate, either (1) at least 5% of our outstanding shares and at least 1% of our outstanding voting power or (2) at least 5% of our outstanding voting power, may
nominate one or more persons for election as directors at a general or special meeting by delivering a written notice of such shareholder’s intent to make such nomination or nominations to our registered office. Each such notice must set
forth all of the details and information as required to be provided in the Companies Law.
|
• |
Compensation Committee and Compensation of Officers. Israeli law, and our Articles of Association, do not require that a compensation committee composed solely of
independent members of our Board of Directors determine (or recommend to the board of directors for determination) an executive officer’s compensation, as required under Nasdaq’s listing standards related to compensation committee
independence and responsibilities; nor do they require that the Company adopt and file a compensation committee charter. Instead, our Compensation Committee has been established and conducts itself in accordance with provisions governing
the composition of and the responsibilities of a compensation committee as set forth in the Companies Law, and is comprised of all of our external directors (who must comprise the majority of the members of the Compensation Committee),
and at least one additional director who is entitled to the same compensation payable to our external directors, and who is not the chairman of our Board of Directors or otherwise employed by or a provider of services to, the Company. If
we qualify as an Eligible Company and opt to follow the exemption provided under the Relief Regulations regarding appointment of external directors and composition of the audit and compensation committees, we will be required at all times
to comply with the U.S. rules and regulations governing the appointment of independent directors and composition of the compensation committee applicable to U.S. domestic issuers instead of complying with the Companies Law provisions
relating to external directors and composition of the compensation committee. Additionally, we comply with the requirements set forth under the Companies Law, pursuant to which transactions with office holders regarding their terms of
office and employment, and a transaction with a controlling shareholder in a company regarding his or her employment and/or his or her terms of office with the company, may require the approval of the compensation committee, the board of
directors and under certain circumstances the shareholders, either in accordance with our previously approved compensation policy or, in special circumstances in deviation therefrom, taking into account certain considerations set forth in
the Companies Law. See “Item 6. Directors, Senior Management and Employees — Board Practices — Compensation Committee” for information regarding the Compensation Committee, and “Item 6. Directors, Senior Management and Employees —
Approval of Related Party Transactions under Israeli Law” for information regarding the special approvals required with respect to approval of terms of office and employment of office holders, pursuant to the Companies Law. The
requirements for shareholder approval of any office holder compensation, and the relevant majority or special majority for such approval, are all as set forth in the Companies Law. Thus, we will seek shareholder approval for all corporate
actions with respect to office holder compensation requiring such approval under the requirements of the Companies Law, including seeking prior approval of the shareholders for the compensation policy and for certain office holder
compensation, rather than seeking approval for such corporate actions in accordance with Nasdaq Listing Rules.
|
• |
Approval of Related Party Transactions. All related party transactions are approved in accordance with the requirements and procedures for approval of interested
party acts and transactions, set forth in sections 268 to 275 of the Companies Law, and the regulations promulgated thereunder, which require the approval of the audit committee, the compensation committee, the board of directors and
shareholders, as may be applicable, for specified transactions, rather than approval by the audit committee or other independent body of our Board of Directors as required under the Nasdaq Rules.
|
• |
Shareholder Approval. We seek shareholder approval for all corporate actions requiring such approval in accordance with the requirements of the Companies Law, which
are different or in addition to the requirements for seeking shareholder approval under Nasdaq Listing Rule 5635, rather than seeking approval for corporation actions in accordance with such listing rules.
|
• |
Equity Compensation Plans. We do not necessarily seek shareholder approval for the establishment of, and amendments to, stock option or equity compensation plans (as
set forth in Nasdaq Listing Rule 5635(c)), as such matters are not subject to shareholder approval under Israeli law. Our equity compensation plan is available to our employees, none of whom are currently U.S. employees, and provides
features necessary to comply with applicable non-U.S. tax laws.
|
Exhibit
Number
|
|
Exhibit Description
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101
|
|
The following financial information from BioLineRx Ltd.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 formatted in XBRL (Extensible Business Reporting Language): (i)
Consolidated Statements of Financial Position at December 31, 2020 and 2019; (ii) Consolidated Statements of Comprehensive Loss for the years ended December 31, 2020, 2019 and 2018; (iii) Statements of Changes in Equity for the years
ended December 31, 2020, 2019 and 2018; (iv) Consolidated Cash Flow Statements for the years ended December 31, 2020, 2019 and 2018; and (v) Notes to the Consolidated Financial Statements.
|
|
BIOLINERX LTD.
|
|
|
|
|
|
|
|
By:
|
/s/ Philip A. Serlin
|
|
|
|
Philip A. Serlin
|
|
|
|
Chief Executive Officer
|
|
/s/ Kesselman & Kesselman
|
Kesselman & Kesselman
|
Certified Public Accountants (Isr.)
|
A member firm of PricewaterhouseCoopers International Ltd.
|
Tel Aviv, Israel
|
February 22, 2021
|
We have served as the Company’s auditor since 2003.
|
Note
|
December 31,
|
|||||||||||
2019
|
2020
|
|||||||||||
in USD thousands
|
||||||||||||
Assets
|
||||||||||||
CURRENT ASSETS
|
||||||||||||
Cash and cash equivalents
|
5
|
5,297
|
16,831
|
|||||||||
Short-term bank deposits
|
6
|
22,192
|
5,756
|
|||||||||
Prepaid expenses
|
108
|
152
|
||||||||||
Other receivables
|
17a
|
|
613
|
141
|
||||||||
Total current assets
|
28,210
|
22,880
|
||||||||||
NON-CURRENT ASSETS
|
||||||||||||
Property and equipment, net
|
8
|
1,816
|
1,341
|
|||||||||
Right-of-use assets, net
|
10
|
1,650
|
1,355
|
|||||||||
Intangible assets, net
|
9
|
21,891
|
21,714
|
|||||||||
Total non-current assets
|
25,357
|
24,410
|
||||||||||
Total assets
|
53,567
|
47,290
|
||||||||||
Liabilities and equity
|
||||||||||||
CURRENT LIABILITIES
|
||||||||||||
Current maturities of long-term loans
|
11, 19
|
2,692
|
3,092
|
|||||||||
Accounts payable and accruals:
|
||||||||||||
Trade
|
17b
|
|
7,794
|
5,918
|
||||||||
Other
|
17b
|
|
1,280
|
1,440
|
||||||||
Lease liabilities
|
10
|
202
|
191
|
|||||||||
Total current liabilities
|
11,968
|
10,641
|
||||||||||
NON-CURRENT LIABILITIES
|
||||||||||||
Warrants
|
12c, 19
|
658
|
10,218
|
|||||||||
Long-term loans, net of current maturities
|
11, 19
|
5,799
|
2,740
|
|||||||||
Lease liabilities
|
10
|
1,762
|
1,661
|
|||||||||
Total non-current liabilities
|
8,219
|
14,619
|
||||||||||
COMMITMENTS AND CONTINGENT LIABILITIES
|
15
|
|||||||||||
Total liabilities
|
20,187
|
25,260
|
||||||||||
EQUITY
|
12
|
|||||||||||
Ordinary shares
|
4,692
|
9,870
|
||||||||||
Share premium
|
265,938
|
279,241
|
||||||||||
Capital reserve
|
12,132
|
12,322
|
||||||||||
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||||||
Accumulated deficit
|
(247,966
|
)
|
(277,987
|
)
|
||||||||
Total equity
|
33,380
|
22,030
|
||||||||||
Total liabilities and equity
|
53,567
|
47,290
|
Note
|
Year ended December 31,
|
|||||||||||||||
2018
|
2019
|
2020
|
||||||||||||||
in USD thousands
|
||||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
17c
|
|
(19,808
|
)
|
(23,438
|
)
|
(18,173
|
)
|
||||||||
SALES AND MARKETING EXPENSES
|
17d
|
|
(1,362
|
)
|
(857
|
)
|
(840
|
)
|
||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
17e
|
|
(4,435
|
)
|
(3,816
|
)
|
(3,914
|
)
|
||||||||
OPERATING LOSS
|
(25,605
|
)
|
(28,111
|
)
|
(22,927
|
)
|
||||||||||
NON-OPERATING INCOME (EXPENSES), NET
|
17f
|
|
2,397
|
4,165
|
(5,701
|
)
|
||||||||||
FINANCIAL INCOME
|
17g
|
|
719
|
777
|
236
|
|||||||||||
FINANCIAL EXPENSES
|
17h
|
|
(473
|
)
|
(2,277
|
)
|
(1,629
|
)
|
||||||||
NET LOSS AND COMPREHENSIVE LOSS
|
(22,962
|
)
|
(25,446
|
)
|
(30,021
|
)
|
||||||||||
in USD
|
||||||||||||||||
LOSS PER ORDINARY SHARE – BASIC AND DILUTED
|
14
|
(0.21
|
)
|
(0.17
|
)
|
(0.12
|
)
|
|||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
|
14
|
108,595,702
|
146,407,055
|
252,844,394
|
Ordinary shares
|
Share premium
|
Capital reserve
|
Other comprehensive
loss |
Accumulated deficit
|
Total
|
|||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2018
|
2,836
|
240,682
|
10,337
|
(1,416
|
)
|
(199,558
|
)
|
52,881
|
||||||||||||||||
CHANGES IN 2018:
|
||||||||||||||||||||||||
Issuance of share capital, net
|
263
|
8,567
|
-
|
-
|
-
|
8,830
|
||||||||||||||||||
Employee stock options exercised
|
11
|
415
|
(380
|
)
|
-
|
-
|
46
|
|||||||||||||||||
Employee stock options forfeited and expired
|
-
|
528
|
(528
|
)
|
-
|
-
|
-
|
|||||||||||||||||
Share-based compensation
|
-
|
-
|
2,526
|
-
|
-
|
2,526
|
||||||||||||||||||
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
(22,962
|
)
|
(22,962
|
)
|
||||||||||||||||
BALANCE AT DECEMBER 31, 2018
|
3,110
|
250,192
|
11,955
|
(1,416
|
)
|
(222,520
|
)
|
41,321
|
||||||||||||||||
CHANGES IN 2019:
|
||||||||||||||||||||||||
Issuance of share capital, net
|
1,580
|
14,165
|
-
|
-
|
-
|
15,745
|
||||||||||||||||||
Employee stock options exercised
|
2
|
83
|
(84
|
)
|
-
|
-
|
1
|
|||||||||||||||||
Employee stock options forfeited and expired
|
-
|
1,498
|
(1,498
|
)
|
-
|
-
|
-
|
|||||||||||||||||
Share-based compensation
|
-
|
-
|
1,759
|
-
|
-
|
1,759
|
||||||||||||||||||
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
(25,446
|
)
|
(25,446
|
)
|
||||||||||||||||
BALANCE AT DECEMBER 31, 2019
|
4,692
|
265,938
|
12,132
|
(1,416
|
)
|
(247,966
|
)
|
33,380
|
||||||||||||||||
CHANGES IN 2020:
|
||||||||||||||||||||||||
Issuance of share capital, net
|
4,777
|
9,395
|
-
|
-
|
-
|
14,172
|
||||||||||||||||||
Warrants exercised
|
393
|
2,826
|
-
|
-
|
-
|
3,219
|
||||||||||||||||||
Employee stock options exercised
|
8
|
228
|
(228
|
)
|
-
|
-
|
8
|
|||||||||||||||||
Employee stock options forfeited and expired
|
-
|
854
|
(854
|
)
|
-
|
-
|
-
|
|||||||||||||||||
Share-based compensation
|
-
|
-
|
1,272
|
-
|
-
|
1,272
|
||||||||||||||||||
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
(30,021
|
)
|
(30,021
|
)
|
||||||||||||||||
BALANCE AT DECEMBER 31, 2020
|
9,870
|
279,241
|
12,322
|
(1,416
|
)
|
(277,987
|
)
|
22,030
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||||||
Net loss
|
(22,962
|
)
|
(25,446
|
)
|
(30,021
|
)
|
||||||
Adjustments required to reflect net cash used in operating activities (see appendix below)
|
(1,230
|
)
|
2,780
|
6,815
|
||||||||
Net cash used in operating activities
|
(24,192
|
)
|
(22,666
|
)
|
(23,206
|
)
|
||||||
CASH FLOWS - INVESTING ACTIVITIES
|
||||||||||||
Realization of long-term investment
|
1,500
|
-
|
-
|
|||||||||
Investments in short-term deposits
|
(26,500
|
)
|
(43,545
|
)
|
(33,500
|
)
|
||||||
Maturities of short-term deposits
|
44,771
|
48,875
|
50,168
|
|||||||||
Purchase of property and equipment
|
(173
|
)
|
(67
|
)
|
-
|
|||||||
Purchase of intangible assets
|
(10,043
|
)
|
(6
|
)
|
-
|
|||||||
Net cash provided by investing activities
|
9,555
|
5,257
|
16,668
|
|||||||||
CASH FLOWS - FINANCING ACTIVITIES
|
||||||||||||
Issuance of share capital and warrants, net of issuance cost
|
3,830
|
20,297
|
21,215
|
|||||||||
Employee stock options exercised
|
46
|
1
|
8
|
|||||||||
Proceeds of long-term loan and warrants, net of issuance costs
|
9,632
|
-
|
-
|
|||||||||
Repayment of loans
|
(411
|
)
|
(889
|
)
|
(3,133
|
)
|
||||||
Repayments of lease liabilities
|
-
|
(215
|
)
|
(224
|
)
|
|||||||
Net cash provided by financing activities
|
13,097
|
19,194
|
17,866
|
|||||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(1,540
|
)
|
1,785
|
11,328
|
||||||||
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
|
5,110
|
3,404
|
5,297
|
|||||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(166
|
)
|
108
|
206
|
||||||||
CASH AND CASH EQUIVALENTS - END OF YEAR
|
3,404
|
5,297
|
16,831
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
APPENDIX
|
||||||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||||||
Income and expenses not involving cash flows:
|
||||||||||||
Depreciation and amortization
|
545
|
940
|
934
|
|||||||||
Long-term prepaid expenses
|
5
|
56
|
-
|
|||||||||
Exchange differences on cash and cash equivalents
|
166
|
(108
|
)
|
(206
|
)
|
|||||||
Fair value adjustments of warrants
|
(1,743
|
)
|
(4,634
|
)
|
5,142
|
|||||||
Share-based compensation
|
2,526
|
1,759
|
1,272
|
|||||||||
Interest and exchange differences on short-term deposits
|
(645
|
)
|
(775
|
)
|
(232
|
)
|
||||||
Interest on loans
|
123
|
647
|
474
|
|||||||||
Gain on realization of long-term investment
|
(500
|
)
|
-
|
-
|
||||||||
Warrant issuance costs
|
-
|
417
|
594
|
|||||||||
Exchange differences on lease liability
|
-
|
154
|
125
|
|||||||||
477
|
(1,544
|
)
|
8,103
|
|||||||||
Changes in operating asset and liability items:
|
||||||||||||
Decrease (increase) in prepaid expenses and other receivables
|
(934
|
)
|
1,106
|
428
|
||||||||
Increase (decrease) in accounts payable and accruals
|
(773
|
)
|
3,218
|
(1,716
|
)
|
|||||||
(1,707
|
)
|
4,324
|
(1,288
|
)
|
||||||||
(1,230
|
)
|
2,780
|
6,815
|
|||||||||
Supplemental information on interest received in cash
|
834
|
868
|
381
|
|||||||||
Supplemental information on interest paid in cash (see Notes 10 and 15)
|
165
|
1,198
|
994
|
|||||||||
Supplemental information on non-cash transactions (see Notes 18, 19 and 12c)
|
5,000
|
147
|
1,251
|
a. |
General
|
b. |
Approval of consolidated financial statements
|
c. |
Change in ratio of ADSs
|
a. |
Basis of presentation
|
a. |
Basis of presentation (cont.)
|
b. |
Principles of consolidation
|
c. |
Functional and reporting currency
|
d. |
Cash equivalents and short-term bank deposits
|
e. |
Property and equipment
|
%
|
|
Computers and communications equipment
|
20-33
|
Office furniture and equipment
|
6-15
|
Laboratory equipment
|
15-20
|
f. |
Intangible assets
|
g. |
Impairment of non-amortized non-financial assets
|
h. |
Financial assets
|
1) |
Classification
|
h. |
Financial assets (cont.)
|
2) |
Recognition and measurement
|
3) |
Impairment
|
i. |
Warrants
|
j. |
Share capital
|
k. |
Trade payables
|
l. |
Deferred taxes
|
m. |
Borrowings
|
n. |
Revenue from contracts with customers
|
• |
identify the contract with a customer;
|
• |
identify the performance obligations in the contract;
|
• |
determine the transaction price;
|
• |
allocate the transaction price to the performance obligations in the contract; and
|
• |
recognize revenue when (or as) the entity satisfies a performance obligation.
|
o. |
Research and development expenses
|
• |
technological feasibility exists for completing development of the intangible asset so that it will be available for use or sale.
|
• |
it is management’s intention to complete development of the intangible asset for use or sale.
|
• |
the Company has the ability to use or sell the intangible asset.
|
• |
it is probable that the intangible asset will generate future economic benefits, including existence of a market for the output of the intangible asset or the intangible asset itself or, if the intangible asset is to be used
internally, the usefulness of the intangible asset.
|
• |
adequate technical, financial and other resources are available to complete development of the intangible asset, as well as the use or sale thereof.
|
• |
the Company has the ability to reliably measure the expenditure attributable to the intangible asset during its development.
|
p. |
Employee benefits
|
1) |
Pension and severance pay obligations
|
2) |
Vacation and recreation pay
|
3) |
Share-based payments
|
• |
including any market performance conditions (for example, the Company’s share price); and
|
• |
excluding the impact of any service and non-market performance vesting conditions (for example, profitability, sales growth targets and the employee remaining with the entity over a specified time period).
|
q. |
Loss per share
|
1) |
Basic
|
2) |
Diluted
|
r. |
Leases
|
r. |
Leases (cont.)
|
Years
|
|
Property
|
11
|
Motor vehicles
|
3
|
s. |
New standards and interpretations not yet adopted
|
a. |
Market risk
|
1) |
Concentration of currency risk
|
December 31, 2020
|
||||||||||||||||||||
Income (loss)
|
Value on
|
Income (loss)
|
||||||||||||||||||
Sensitive instrument
|
10% increase
|
5% increase
|
balance sheet
|
5% decrease
|
10% decrease
|
|||||||||||||||
in USD thousands
|
||||||||||||||||||||
NIS-linked balances:
|
||||||||||||||||||||
Cash and cash equivalents
|
(341
|
)
|
(179
|
)
|
3,755
|
198
|
417
|
|||||||||||||
Other receivables
|
(13
|
)
|
(7
|
)
|
141
|
7
|
16
|
|||||||||||||
Trade payables
|
47
|
25
|
(518
|
)
|
(27
|
)
|
(58
|
)
|
||||||||||||
Other payables
|
117
|
61
|
(1,286
|
)
|
(68
|
)
|
(143
|
)
|
||||||||||||
Total NIS-linked balances
|
(190
|
)
|
(100
|
)
|
2,092
|
110
|
232
|
|||||||||||||
Euro-linked trade payables
|
(203
|
)
|
(106
|
)
|
(2,232
|
)
|
248
|
117
|
||||||||||||
Total
|
(393
|
)
|
(206
|
)
|
(140
|
)
|
358
|
349
|
December 31, 2019
|
||||||||||||||||||||
Income (loss)
|
Value on
|
Income (loss)
|
||||||||||||||||||
Sensitive instrument
|
10% increase
|
5% increase
|
balance sheet
|
5% decrease
|
10% decrease
|
|||||||||||||||
in USD thousands
|
||||||||||||||||||||
NIS-linked balances:
|
||||||||||||||||||||
Cash and cash equivalents
|
(53
|
)
|
(28
|
)
|
583
|
65
|
31
|
|||||||||||||
Other receivables
|
(56
|
)
|
(29
|
)
|
613
|
68
|
32
|
|||||||||||||
Trade payables
|
227
|
119
|
(2,501
|
)
|
(278
|
)
|
(132
|
)
|
||||||||||||
Other payables
|
71
|
37
|
(780
|
)
|
(87
|
)
|
(41
|
)
|
||||||||||||
Total NIS-linked balances
|
189
|
99
|
(2,085
|
)
|
(232
|
)
|
(110
|
)
|
||||||||||||
Euro-linked trade payables
|
(168
|
)
|
(88
|
)
|
(1,851
|
)
|
206
|
97
|
||||||||||||
Total
|
21
|
11
|
(3,936
|
)
|
(26
|
)
|
(13
|
)
|
a. |
Market risk (cont.)
|
1) |
Concentration of currency risk (cont.)
|
Exchange
rate of NIS
per $1
|
Exchange
rate of Euro
per $1
|
|||||||
As of December 31:
|
||||||||
2018
|
3.748
|
0.873
|
||||||
2019
|
3.456
|
0.891
|
||||||
2020
|
3.215
|
0.815
|
||||||
Percentage increase (decrease) in USD exchange rate:
|
||||||||
2019
|
(7.8
|
)%
|
2.1
|
%
|
||||
2020
|
(7.0
|
)%
|
(8.5
|
)%
|
December 31, 2019
|
December 31, 2020
|
|||||||||||||||||||||||
Dollar
|
NIS
|
Other currencies
|
Dollar
|
NIS
|
Other Currencies
|
|||||||||||||||||||
USD in thousands
|
USD in thousands
|
|||||||||||||||||||||||
Assets:
|
||||||||||||||||||||||||
Current assets:
|
||||||||||||||||||||||||
Cash and cash equivalents
|
4,082
|
583
|
632
|
12,488
|
3,755
|
588
|
||||||||||||||||||
Short term bank deposits
|
22,192
|
-
|
-
|
5,756
|
-
|
-
|
||||||||||||||||||
Other receivables
|
-
|
613
|
-
|
-
|
141
|
-
|
||||||||||||||||||
26,274
|
1,196
|
632
|
18,244
|
3,896
|
588
|
|||||||||||||||||||
Liabilities:
|
||||||||||||||||||||||||
Current liabilities:
|
||||||||||||||||||||||||
Current maturities of long-term loans
|
2,692
|
-
|
-
|
3,092
|
-
|
-
|
||||||||||||||||||
Accounts payable and accruals:
|
||||||||||||||||||||||||
Trade
|
2,772
|
2,501
|
2,521
|
2,455
|
518
|
2,945
|
||||||||||||||||||
Other
|
500
|
780
|
-
|
154
|
1,286
|
-
|
||||||||||||||||||
Non-current liabilities
|
||||||||||||||||||||||||
Long-term loans, net of current maturities
|
5,799
|
-
|
-
|
2,740
|
-
|
-
|
||||||||||||||||||
11,763
|
3,281
|
2,521
|
8,441
|
1,804
|
2,945
|
|||||||||||||||||||
Net asset value
|
14,511
|
(2,085
|
)
|
(1,889
|
)
|
9,803
|
2,092
|
(2,357
|
)
|
a. |
Market risk (cont.)
|
2) |
Fair value of financial instruments
|
3) |
Exposure to market risk and management thereof
|
4) |
Interest rate risk
|
b. |
Credit risk
|
December 31,
|
||||||||
2019
|
2020
|
|||||||
in USD thousands
|
||||||||
Assets:
|
||||||||
Cash and cash equivalents
|
5,297
|
16,831
|
||||||
Short-term bank deposits
|
22,192
|
5,756
|
||||||
Other receivables
|
613
|
141
|
||||||
Total
|
28,102
|
22,728
|
c. |
Liquidity risk
|
d. |
Fair value of financial instruments
|
Level 1
|
Quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
Level 2
|
Inputs, other than quoted prices included within level 1 that are observable for the asset or liability, either directly (as prices) or indirectly (derived from prices).
|
Level 3
|
Inputs for the asset or liability that are not based on observable market data (unobservable inputs).
|
e. |
Changes in financial liabilities with cash flows included in financing activities
|
Long-term loans
|
Warrants
|
Total
|
||||||||||
in USD thousands
|
||||||||||||
Balance as of January 1, 2019
|
8,733
|
323
|
9,056
|
|||||||||
Changes during the year 2019:
|
||||||||||||
Cash flows received
|
-
|
4,969
|
4,969
|
|||||||||
Cash flows paid
|
(889
|
)
|
-
|
(889
|
)
|
|||||||
Amounts recognized through profit and loss
|
647
|
(4,634
|
)
|
(3,987
|
)
|
|||||||
Balance as of December 31, 2019
|
8,491
|
658
|
9,149
|
|||||||||
Changes during the year 2020:
|
||||||||||||
Cash flows received
|
-
|
5,669
|
5,669
|
|||||||||
Cash flows paid
|
(3,133
|
)
|
-
|
(3,133
|
)
|
|||||||
Share premium resulting from exercise of warrants
|
-
|
(1,251
|
)
|
(1,251
|
)
|
|||||||
Amounts recognized through profit and loss
|
474
|
5,142
|
5,616
|
|||||||||
Balance as of December 31, 2020
|
5,832
|
10,218
|
16,050
|
f. |
Fair value measurement of warrants using significant unobservable inputs (level 3)
|
Warrants
|
||||
in USD thousands
|
||||
Balance as of January 1, 2018
|
1,205
|
|||
Changes during 2018:
|
||||
Issuances
|
861
|
|||
Changes in fair value through profit and loss
|
(1,743
|
)
|
||
Balance as of December 31, 2018
|
323
|
|||
Changes during 2019:
|
||||
Issuances
|
4,969
|
|||
Changes in fair value through profit and loss
|
(4,634
|
)
|
||
Balance as of December 31, 2019
|
658
|
|||
Changes during 2020:
|
||||
Issuances
|
5,669
|
|||
Exercises
|
(1,251
|
)
|
||
Changes in fair value through profit and loss
|
5,142
|
|||
Balance as of December 31, 2020
|
10,218
|
December 31,
|
||||||||
2019
|
2020
|
|||||||
in USD thousands
|
||||||||
Cash on hand and in bank
|
4,922
|
11,550
|
||||||
Short-term bank deposits
|
375
|
5,281
|
||||||
5,297
|
16,831
|
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2017
|
2018
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2018
|
||||||||||||||||||||||||||||||||||||||||
Office furniture and equipment
|
200
|
-
|
-
|
200
|
60
|
22
|
-
|
82
|
140
|
118
|
||||||||||||||||||||||||||||||
Computers and communications equipment
|
755
|
9
|
-
|
764
|
438
|
60
|
-
|
498
|
317
|
266
|
||||||||||||||||||||||||||||||
Laboratory equipment
|
1,368
|
164
|
-
|
1,532
|
829
|
153
|
-
|
982
|
539
|
550
|
||||||||||||||||||||||||||||||
Leasehold improvements
|
2,028
|
-
|
-
|
2,028
|
519
|
216
|
-
|
735
|
1,509
|
1,293
|
||||||||||||||||||||||||||||||
4,351
|
173
|
-
|
4,524
|
1,846
|
451
|
-
|
2,297
|
2,505
|
2,227
|
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2018
|
2019
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2019
|
||||||||||||||||||||||||||||||||||||||||
Office furniture and equipment
|
200
|
7
|
-
|
207
|
82
|
13
|
-
|
95
|
118
|
112
|
||||||||||||||||||||||||||||||
Computers and communications equipment
|
764
|
31
|
-
|
795
|
498
|
63
|
-
|
561
|
266
|
234
|
||||||||||||||||||||||||||||||
Laboratory equipment
|
1,532
|
29
|
-
|
1,561
|
982
|
185
|
-
|
1,167
|
550
|
394
|
||||||||||||||||||||||||||||||
Leasehold improvements
|
2,028
|
-
|
-
|
2,028
|
735
|
217
|
-
|
952
|
1,293
|
1,076
|
||||||||||||||||||||||||||||||
4,524
|
67
|
-
|
4,591
|
2,297
|
478
|
-
|
2,775
|
2,227
|
1,816
|
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2019
|
2020
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2020
|
||||||||||||||||||||||||||||||||||||||||
Office furniture and equipment
|
207
|
-
|
-
|
207
|
95
|
14
|
-
|
109
|
112
|
98
|
||||||||||||||||||||||||||||||
Computers and communications equipment
|
795
|
-
|
-
|
795
|
561
|
48
|
-
|
609
|
234
|
186
|
||||||||||||||||||||||||||||||
Laboratory equipment
|
1,561
|
-
|
-
|
1,561
|
1,167
|
184
|
-
|
1,351
|
394
|
210
|
||||||||||||||||||||||||||||||
Leasehold improvements
|
2,028
|
-
|
-
|
2,028
|
952
|
229
|
-
|
1,181
|
1,076
|
847
|
||||||||||||||||||||||||||||||
4,591
|
-
|
-
|
4,591
|
2,775
|
475
|
-
|
3,250
|
1,816
|
1,341
|
Cost
|
Accumulated depreciation and impairment
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2017
|
2018
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2018
|
||||||||||||||||||||||||||||||||||||||||
Intellectual property
|
6,896
|
15,000
|
-
|
21,896
|
96
|
-
|
-
|
96
|
6,800
|
21,800
|
||||||||||||||||||||||||||||||
Computer software
|
567
|
43
|
-
|
610
|
344
|
94
|
-
|
438
|
223
|
172
|
||||||||||||||||||||||||||||||
7,463
|
15,043
|
-
|
22,506
|
440
|
94
|
-
|
534
|
7,023
|
21,972
|
Cost
|
Accumulated depreciation and impairment
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2018
|
2019
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2019
|
||||||||||||||||||||||||||||||||||||||||
Intellectual property
|
21,896
|
-
|
-
|
21,896
|
96
|
-
|
-
|
96
|
21,800
|
21,800
|
||||||||||||||||||||||||||||||
Computer software
|
610
|
6
|
-
|
616
|
438
|
87
|
-
|
525
|
172
|
91
|
||||||||||||||||||||||||||||||
22,506
|
6
|
-
|
22,512
|
534
|
87
|
-
|
621
|
21,972
|
21,891
|
Cost
|
Accumulated depreciation and impairment
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2019
|
2020
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2020
|
||||||||||||||||||||||||||||||||||||||||
Intellectual property
|
21,896
|
-
|
104
|
21,792
|
96
|
-
|
-
|
96
|
21,800
|
21,696
|
||||||||||||||||||||||||||||||
Computer software
|
616
|
-
|
-
|
616
|
525
|
73
|
-
|
598
|
91
|
18
|
||||||||||||||||||||||||||||||
22,512
|
-
|
104
|
22,408
|
621
|
73
|
-
|
694
|
21,891
|
21,714
|
a. |
Right-of-use assets
|
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2018
|
2019
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2019
|
||||||||||||||||||||||||||||||||||||||||
Property
|
1,552
|
-
|
-
|
1,552
|
-
|
135
|
-
|
135
|
-
|
1,417
|
||||||||||||||||||||||||||||||
Motor vehicles
|
326
|
172
|
(65
|
)
|
433
|
-
|
240
|
(40
|
)
|
200
|
-
|
233
|
||||||||||||||||||||||||||||
1,878
|
172
|
(65
|
)
|
1,985
|
-
|
375
|
(40
|
)
|
335
|
-
|
1,650
|
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2019
|
2020
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2020
|
||||||||||||||||||||||||||||||||||||||||
Property
|
1,552
|
-
|
-
|
1,552
|
135
|
135
|
-
|
270
|
1,417
|
1,282
|
||||||||||||||||||||||||||||||
Motor vehicles
|
433
|
-
|
(37
|
)
|
396
|
200
|
147
|
(24
|
)
|
323
|
233
|
73
|
||||||||||||||||||||||||||||
1,985
|
-
|
(37
|
)
|
1,948
|
335
|
282
|
(24
|
)
|
593
|
1,650
|
1,355
|
b. |
Lease liabilities
|
Balance at
|
Additions
|
Deletions
|
Interest expense
|
Exchange differences
|
Payments
|
Balance at
|
||||||||||||||||||||||
beginning
|
during
|
during
|
during
|
during
|
during
|
end of
|
||||||||||||||||||||||
of year
|
year
|
year
|
year
|
year
|
year
|
year
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
Composition in 2019
|
||||||||||||||||||||||||||||
Property
|
1,552
|
-
|
-
|
257
|
127
|
(272
|
)
|
1,664
|
||||||||||||||||||||
Motor vehicles
|
326
|
172
|
(25
|
)
|
73
|
27
|
(273
|
)
|
300
|
|||||||||||||||||||
1,878
|
172
|
(25
|
)
|
330
|
154
|
(545
|
)
|
1,964
|
Balance at
|
Additions
|
Deletions
|
Interest expense
|
Exchange differences
|
Payments
|
Balance at
|
||||||||||||||||||||||
beginning
|
during
|
during
|
during
|
during
|
during
|
end of
|
||||||||||||||||||||||
of year
|
year
|
year
|
year
|
year
|
year
|
year
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
Composition in 2020
|
||||||||||||||||||||||||||||
Property
|
1,664
|
-
|
-
|
228
|
122
|
(281
|
)
|
1,733
|
||||||||||||||||||||
Motor vehicles
|
300
|
-
|
(20
|
)
|
22
|
10
|
(193
|
)
|
119
|
|||||||||||||||||||
1,964
|
-
|
(20
|
)
|
250
|
132
|
(474
|
)
|
1,852
|
Year ended December 31,
|
||||||||
2019
|
2020
|
|||||||
in USD thousands
|
||||||||
Composition of lease liabilities:
|
||||||||
Current lease liabilities
|
||||||||
Property
|
53
|
81
|
||||||
Motor vehicles
|
149
|
110
|
||||||
202
|
191
|
|||||||
Non-current lease liabilities
|
||||||||
Property
|
1,611
|
1,658
|
||||||
Motor vehicles
|
151
|
3
|
||||||
1,762
|
1,661
|
|||||||
1,964
|
1,852
|
c. |
Additional disclosures
|
1) |
The Company leases its premises under an operating lease agreement entered into in August 2014. Payments under the lease commenced in June 2015, and the initial term of the lease expired in June 2020. The Company has exercised its
option to extend the lease through June 30, 2025 and has the option to extend the lease for two additional lease periods totaling up to 5 additional years, each option at a 5% increase to the preceding lease payment amount. The monthly
lease fee is $24,000. In addition, the Company pays building maintenance charges of $8,000 per month.
|
2) |
The Company has entered into operating lease agreements in connection with a number of vehicles. The lease periods are generally for three years. The annual lease fees, linked to the CPI, are $275,000. To secure the terms of the
lease agreements, the Company has prepaid approximately two months of lease payments to the leasing companies. These amounts were recorded as prepaid expenses until 2018.
|
3) |
As of December 31, 2020, minimum future rental payments (taking into consideration the aforementioned extension periods) under the leases were as follows:
|
Year
|
Property
|
Motor vehicles
|
Total
|
|||||||||
in USD thousands
|
||||||||||||
2021
|
314
|
105
|
419
|
|||||||||
2022
|
314
|
22
|
336
|
|||||||||
2023
|
314
|
-
|
314
|
|||||||||
2024
|
329
|
-
|
329
|
|||||||||
2025-2030
|
1,868
|
-
|
1,868
|
|||||||||
3,139
|
127
|
3,266
|
a. |
Composition
|
December 31,
|
||||||||
2019
|
2020
|
|||||||
in USD thousands
|
||||||||
Bank loan
|
63
|
-
|
||||||
Loan from Kreos Capital (see Note 19)
|
8,428
|
5,832
|
||||||
8,491
|
5,832
|
|||||||
Less current maturities:
|
||||||||
Bank loan
|
(63
|
)
|
-
|
|||||
Loan from Kreos Capital
|
(2,629
|
)
|
(3,092
|
)
|
||||
Total current maturities
|
(2,692
|
)
|
(3,092
|
)
|
||||
Total long-term loans
|
5,799
|
2,740
|
b. |
Future repayments
|
in USD thousands
|
||||
2021
|
3,092
|
|||
2022
|
2,740
|
|||
5,832
|
a. |
Share capital
|
Number of Ordinary Shares
|
||||||||
December 31,
|
||||||||
2019
|
2020
|
|||||||
Authorized share capital
|
500,000,000
|
1,500,000,000
|
||||||
Issued and paid-up share capital
|
171,269,528
|
349,169,545
|
In USD and NIS Amounts
|
||||||||
December 31,
|
||||||||
2019
|
2020
|
|||||||
Authorized share capital (in NIS)
|
50,000,000
|
150,000,000
|
||||||
Issued and paid-up share capital (in NIS)
|
17,126,953
|
34,916,955
|
||||||
Issued and paid-up share capital (in USD)
|
4,691,734
|
9,869,795
|
b. |
Rights related to shares
|
c. |
Changes in the Company’s equity
|
1) |
In July 2017, the Company completed a direct placement to one of its shareholders for aggregate gross proceeds of $9.6 million. The placement consisted of 566,372 ADSs, Series A warrants to purchase an additional 198,230 ADSs and
Series B warrants to purchase an additional 198,230 ADSs. The Series A warrants have an exercise price of $30.00 per ADS and are exercisable for a term of four years. The Series B warrants have an exercise price of $60.00 per ADS and
are also exercisable for a term of four years. Net proceeds from the transaction were $9.5 million, after deducting fees and expenses.
|
2) |
In October 2018, the Company entered into a loan agreement with Kreos Capital. In connection with the loan, Kreos Capital received warrants to purchase 63,837 ADSs at an exercise price of $14.10 per ADS. For more information see Note
19.
|
c. |
Changes in the Company’s equity (cont.)
|
3) |
In February 2019, the Company completed an underwritten public offering of 1,866,667 of its ADSs and warrants to purchase 1,866,667 ADSs, at a public offering price of $8.25 per ADS and accompanying warrant. The warrants are
exercisable immediately, expire five years from the date of issuance and have an exercise price of $11.25 per ADS. The offering raised a total of $15.4 million, with net proceeds of $14.1 million, after deducting fees and expenses. The
amount of the offering consideration initially allocated to the warrants was $5.0 million. Total issuance costs initially allocated to the warrants were $0.4 million.
|
4) |
In May and June 2020, the Company sold in registered direct offerings an aggregate of 7,653,145 ADSs at a price of $1.75 per ADS. In concurrent private placements, the Company issued to investors in the offerings unregistered
warrants to purchase 7,653,145 ADSs. The warrants are exercisable immediately, expire two and half years from the date of issuance and have an exercise price of $2.25 per ADS. In addition, the Company granted to the placement agent’s
designees, as part of the placement fees, warrants to purchase 382,657 ADSs. These warrants are exercisable immediately, expire two and half years from the date of issuance and have an exercise price of $2.1875 per ADS. The offerings
raised a total of $13.4 million, with net proceeds of $12.0 million, after deducting fees and expenses. The amount of the offering consideration initially allocated to the warrants was $5.7 million. Total issuance costs initially
allocated to the warrants were $0.6 million.
|
c. |
Changes in the Company’s equity (cont.)
|
4) |
(cont.)
|
5) |
See Note 20 for information regarding the issuance of ADSs and warrants after the balance sheet date.
|
d. |
Share purchase agreements
|
1) |
In October 2017, the Company entered into an at-the-market (“ATM”) sales agreement with BTIG, LLC (“BTIG”), pursuant to which the Company was entitled, at its sole discretion, to offer and sell through BTIG, acting as sales agent,
ADSs having an aggregate offering price of up to $30.0 million throughout the period during which the ATM facility remained in effect. The Company agreed to pay BTIG a commission of 3.0% of the gross proceeds from the sale of ADSs under
the facility. During the year ended December 31, 2020, the Company issued a total of 676,750 ADSs, for total net proceeds of $1.4 million, under the ATM facility. In September 2020, the Company terminated the agreement with BTIG. During
the entire term of the agreement, an aggregate of 2,923,552 ADSs were sold under the facility for total gross proceeds of $13.0 million.
|
2) |
In September 2020, the Company entered into a new ATM sales agreement with H.C. Wainwright & Co., LLC (“HCW”), pursuant to which the Company is entitled, at its sole discretion, to offer and sell through HCW, acting as sales
agent, ADSs having an aggregate offering price of up to $25.0 million throughout the period during which the ATM facility remains in effect. The Company agreed to pay HCW a commission of 3.0% of the gross proceeds from the sale of ADSs
under the facility. Expenses associated with establishment of the ATM facility with HCW, amounting to $0.2 million, were recorded in non-operating expenses during the period. As of December 31, 2020, an aggregate of 2,635,733 ADSs had
been sold under the facility, resulting in net proceeds of $5.9 million.
|
e. |
Share-based payments
|
1) |
Share Incentive plan – general
|
e. |
Share-based payments (cont.)
|
2) |
Employee share incentive plan:
|
Year ended December 31,
|
||||||||||||||||||||||||
2018
|
2019
|
2020
|
||||||||||||||||||||||
Number
of options |
Weighted average exercise price
(in NIS)
|
Number
of options |
Weighted average exercise price
(in NIS)
|
Number
of options |
Weighted average exercise price
(in NIS)
|
|||||||||||||||||||
Outstanding at beginning of year
|
10,651,097
|
4.4
|
11,459,697
|
4.2
|
19,358,913
|
2.6
|
||||||||||||||||||
Granted
|
2,853,080
|
2.8
|
11,057,600
|
1.3
|
18,689,300
|
0.5
|
||||||||||||||||||
Forfeited and expired
|
(1,649,090
|
)
|
4.0
|
(3,084,834
|
)
|
3.9
|
(1,776,037
|
)
|
2.2
|
|||||||||||||||
Exercised
|
(395,390
|
)
|
0.4
|
(73,550
|
)
|
0.1
|
(290,597
|
)
|
0.1
|
|||||||||||||||
Outstanding at end of year*
|
11,459,697
|
4.2
|
19,358,913
|
2.6
|
35,981,579
|
1.5
|
||||||||||||||||||
Exercisable at end of year
|
4,489,816
|
5.9
|
5,353,089
|
5.1
|
11,535,679
|
3.2
|
* |
As of December 31, 2018, 2019 and 2020, includes 1,163,018, 2,225,704 and 2,421,799 PSUs at an exercise price of 0.10 NIS (par value of ordinary shares), for which performance obligations have not been met.
|
e. |
Share-based payments (cont.)
|
2) |
Employee share incentive plan (cont.):
|
As of December 31,
|
|||||||||||||||||||||||||
2018
|
2019
|
2020
|
|||||||||||||||||||||||
Range of
exercise prices
(in NIS)
|
Number
of options outstanding |
Weighted average remaining contractual life (in yrs.)
|
Number
of options outstanding |
Weighted average remaining contractual life (in yrs.)
|
Number
of options outstanding |
Weighted average remaining contractual life (in yrs.)
|
|||||||||||||||||||
Up to 2.00
|
1,416,176
|
8.8
|
11,676,900
|
9.9
|
28,888,767
|
9.3
|
|||||||||||||||||||
2.01-5.00
|
8,215,166
|
8.1
|
6,341,033
|
7.3
|
5,866,532
|
6.3
|
|||||||||||||||||||
5.01-10.00
|
1,089,875
|
4.3
|
822,300
|
3.9
|
707,600
|
3.1
|
|||||||||||||||||||
10.01-20.00
|
738,480
|
3.3
|
518,680
|
3.2
|
518,680
|
1.9
|
|||||||||||||||||||
11,459,697
|
7.5
|
19,358,913
|
8.6
|
35,981,579
|
8.6
|
2018
|
2019
|
2020
|
||||||||||
Expected dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
Expected volatility
|
63
|
%
|
61
|
%
|
63
|
%
|
||||||
Risk-free interest rate
|
2
|
%
|
3
|
%
|
1
|
%
|
||||||
Expected life of options (in years)
|
6
|
6
|
6
|
e. |
Share-based payments (cont.)
|
3) |
Repricing of employee stock options
|
4) |
Stock options to consultants
|
a. |
Corporate taxation in Israel
|
b. |
Approved enterprise benefits
|
c. |
Tax loss carryforwards
|
d. |
Tax assessments
|
e. |
Theoretical taxes
|
Year ended December 31,
|
||||||||||||||||||||||||
2018
|
2019
|
2020
|
||||||||||||||||||||||
in USD
|
in USD
|
in USD
|
||||||||||||||||||||||
thousands
|
thousands
|
thousands
|
||||||||||||||||||||||
Loss before taxes
|
23.0
|
%
|
(22,962
|
)
|
23.0
|
%
|
(25,446
|
)
|
23.0
|
%
|
(30,021
|
)
|
||||||||||||
Theoretical tax benefit
|
(5,281
|
)
|
(5,853
|
)
|
(6,905
|
)
|
||||||||||||||||||
Disallowed deductions (tax exempt income):
|
||||||||||||||||||||||||
Loss (gain) on adjustment of warrants to fair value
|
(401
|
)
|
(1,054
|
)
|
(1,280
|
)
|
||||||||||||||||||
Share-based compensation
|
581
|
405
|
292
|
|||||||||||||||||||||
Other
|
10
|
10
|
11
|
|||||||||||||||||||||
Increase in taxes for tax losses and timing differences incurred in the reporting year for which deferred taxes were not created
|
5,091
|
6,492
|
7,882
|
|||||||||||||||||||||
Taxes on income for the reported year
|
-
|
-
|
-
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Loss attributed to ordinary shares
|
(22,962
|
)
|
(25,446
|
)
|
(30,021
|
)
|
||||||
in thousands
|
||||||||||||
Number of shares used in basic calculation
|
108,596
|
146,407
|
252,844
|
|||||||||
in USD
|
||||||||||||
Basic and diluted loss per ordinary share
|
(0.21
|
)
|
(0.17
|
)
|
(0.12
|
)
|
a. |
Commitments
|
1) |
Obligation to pay royalties to the State of Israel
|
a. |
Commitments (cont.)
|
2) |
Licensing agreements
|
a. |
Commitments (cont.)
|
2) |
Licensing agreements (cont.)
|
3) |
Commitments in respect of Agalimmune
|
4) |
Purchase orders
|
b. |
Contingent liabilities
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Benefits to related parties:
|
||||||||||||
Compensation and benefits to senior management, including benefit component of equity instrument grants
|
2,680
|
1,934
|
2,391
|
|||||||||
Number of individuals to which this benefit related
|
6
|
4
|
4
|
|||||||||
Compensation and benefits to directors, including benefit component of equity instrument grants
|
307
|
280
|
373
|
|||||||||
Number of individuals to which this benefit related
|
7
|
7
|
7
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Salaries and other short-term employee benefits
|
1,669
|
1,415
|
1,656 |
|||||||||
Post-employment benefits
|
137
|
115
|
126
|
|||||||||
Other long-term benefits
|
35
|
31
|
33
|
|||||||||
Share-based compensation
|
1,146
|
653
|
949
|
|||||||||
2,987
|
2,214
|
2,764
|
a. |
Other receivables
|
December 31,
|
||||||||
2019
|
2020
|
|||||||
in USD thousands
|
||||||||
Government institutions
|
612
|
139
|
||||||
Other
|
1
|
2
|
||||||
613
|
141
|
b. |
Accounts payable and accruals
|
December 31,
|
||||||||
2019
|
2020
|
|||||||
in USD thousands
|
||||||||
1) Trade:
|
||||||||
Accounts payable:
|
||||||||
Overseas
|
5,178
|
4,795
|
||||||
In Israel
|
2,616
|
1,123
|
||||||
7,794
|
5,918
|
|||||||
2) Other:
|
||||||||
Accrued expenses
|
727
|
884
|
||||||
Accrual for vacation and recreation pay
|
253
|
287
|
||||||
Payroll and related expenses
|
293
|
266
|
||||||
Other
|
7
|
3
|
||||||
1,280
|
1,440
|
c. |
Research and development expenses
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Research and development services
|
11,609
|
16,029
|
11,696
|
|||||||||
Payroll and related expenses
|
5,704
|
4,977
|
4,087
|
|||||||||
Lab, occupancy and telephone
|
993
|
782
|
771
|
|||||||||
Professional fees
|
688
|
504
|
680
|
|||||||||
Depreciation and amortization
|
424
|
862
|
864
|
|||||||||
Other
|
390
|
284
|
75
|
|||||||||
19,808
|
23,438
|
18,173
|
d. |
Sales and marketing expenses
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Marketing
|
291
|
296
|
585
|
|||||||||
Payroll and related expenses
|
973
|
503
|
234
|
|||||||||
Overseas travel
|
98
|
58
|
21
|
|||||||||
1,362
|
857
|
840
|
e. |
General and administrative expenses
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Payroll and related expenses
|
2,510
|
1,881
|
2,098
|
|||||||||
Professional fees
|
1,142
|
1,193
|
1,044
|
|||||||||
Insurance
|
221
|
298
|
603
|
|||||||||
Depreciation
|
27
|
78
|
70
|
|||||||||
Other
|
535
|
366
|
99
|
|||||||||
4,435
|
3,816
|
3,914
|
f. |
Non-operating income (expenses), net
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Issuance costs
|
(90
|
)
|
(417
|
)
|
(784
|
)
|
||||||
Changes in fair value of warrants
|
1,743
|
4,634
|
(5,142
|
)
|
||||||||
Gain from realization of long-term investment
|
500
|
-
|
-
|
|||||||||
Other
|
244
|
(52
|
)
|
225
|
||||||||
2,397
|
4,165
|
(5,701
|
)
|
g. |
Financial income
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Interest income and exchange differences
|
719 | 777 |
236
|
|||||||||
719
|
777
|
236
|
h. |
Financial expenses
|
Year ended December 31,
|
||||||||||||
2018
|
2019
|
2020
|
||||||||||
in USD thousands
|
||||||||||||
Interest expense
|
290
|
1,829
|
1,470
|
|||||||||
Exchange differences
|
162
|
424
|
137
|
|||||||||
Bank commissions
|
21
|
24
|
22
|
|||||||||
473
|
2,277
|
1,629
|
a. |
In January 2021, the Company completed an underwritten public offering of 14,375,000 of its ADSs at a public offering price of $2.40 per ADS. The offering raised total gross proceeds of $34.5 million, with net proceeds of $31.4
million after deducting fees and expenses. In addition, warrants to purchase 718,750 ADSs were granted to the underwriters. These warrants are exercisable immediately, expire five years from the date of issuance and have an exercise
price of $3.00 per ADS.
|
b. |
During January and February 2021, 4,364,391 warrants for the purchase of ADSs, issued in the May and June 2020 financings (see Note 12c(4)), were exercised, resulting in gross proceeds to the Company of
$9.8 million.
|
1. |
Name of Company
|
2. |
Goals of the Company
|
3. |
Interpretation
|
3.1 |
Any statement in the singular shall also include the plural and vice versa; any statement in the masculine shall also include the feminine and vice versa.
|
3.2 |
Except insofar as these Articles include special definitions of certain terms, any word and expression in these Articles shall have the meaning attributed thereto in the Companies Law, 5759-1999 (in these Articles – “the Companies Law,”) unless this contradicts the written matter or the content thereof.
|
3.3 |
To prevent doubt it is clarified that regarding matters regulated in the Companies Law in such manner that the arrangements in these matters may be conditioned in the Articles, and in cases in which these Articles do not include
different provisions from those in the Companies Law, the provisions of the Companies Law shall apply.
|
3.4 |
It is hereby clarified that the provisions of the Articles of Association of the Company as detailed below are subject to the provisions of the Companies Law, the Securities Law, and any law.
|
4. |
The Share Capital of the Company and the Rights Attached to Shares
|
4.1 |
The registered capital of the Company is NIS 150,000,000, divided into 1,500,000,000 ordinary shares with a nominal value of NIS 0.10 each.
|
4.2 |
The ordinary shares shall entitle their owners to –
|
4.2.1 |
An equal right to participate in and vote at the general meetings of the Company, whether ordinary meetings or extraordinary meetings. Each of the shares in the Company shall entitle its owner present at the meeting and participating in
the vote in person, by proxy, or by means of a letter of voting, to one vote;
|
4.2.2 |
An equal right to participate in the distribution of dividends, whether in cash or in benefit shares, in the distribution of assets, or in any other distribution, according to the proportionate nominal value of the shares held thereby;
|
4.2.3 |
An equal right to participate in the distribution of the surplus assets of the Company in the event of its liquidation in accordance with the proportionate nominal value of the shares held thereby.
|
4.3 |
The Board of Directors is entitled to issue shares and other convertible securities or securities that may be realized as shares up to the limit of the Company’s registered capital. For the purpose of calculating the limit of the
registered capital, convertible securities or securities that may be realized as shares shall be considered to have been converted or realized as of their date of issue.
|
5. |
Limited Liability
|
6. |
Joint Shares and Share Certificates
|
6.1 |
The owner of a share registered in the registry of shareholders is entitled to receive from the Company, without payment and within a period of three months following the allocation or the registration of transfer, one share certificate
stamped with the Company’s stamp regarding all the shares registered in his name, which certificate shall detail the number of shares. In the event of a jointly owned share, the Company shall issue one share certificate for all the joint
owners of the share, and the delivery of such a certificate to one of the partners shall be considered delivery to them all.
Each share certificate shall bear the signature of at least one director, the Chief Executive Officer or the Chief Financial and Operating Officer, together with the Company stamp or its printed name.
|
6.2 |
A share certificate that has been defaced, destroyed, or lost may be renewed on the basis of such proof and guarantees as shall be required by the Company from time to time.
|
7. |
The Company’s Reliefs relating to Shares that Have Not Been Fully Paid
|
7.1 |
If any or all of the remuneration the shareholder undertook to pay the Company in return for his shares has not been paid by such date and on such conditions as established in the conditions for the allocation of his shares and/or in the
payment request as stated in section 7.2 below, the Company is entitled, by way of a decision of the Board of Directors, to forfeit the shares whose remuneration has not been fully paid. The forfeiture of shares shall take place provided
that the Company has sent the shareholder written warning of its intention to forfeit the shares after at least 7 days from the date of receipt of the warning, insofar as payment shall not be made during the period determined in the letter
of warning.
|
7.2 |
If, in accordance with the conditions of allocation of the shares, there is no fixed date for the payment of any part of the price to be paid on account thereof, the Board of Directors is entitled, from time to time, to present payment
requests to the shareholders on account of monies not yet removed for the shares they hold, and each shareholder shall be obliged to pay the Company the amount requested on the date determined as stated, provided that he shall receive prior
notice of 14 days of the date and place of payment (hereinafter – “the Payment Request.”) The notification shall specify that non-payment by or before the determined date and in the specified place
may lead to the forfeiture of the shares regarding which payment is requested. A Payment Request may be nullified or postponed to another date, all as shall be decided by the Board of Directors.
|
7.3 |
Unless otherwise determined in the conditions of allocations of the shares, a shareholder shall not be entitled to receive a dividend or to exercise any right as a shareholder on account of shares that have not yet been fully paid.
|
7.4 |
Persons who are the joint owners of a share shall be liable jointly and severally for payment of the amounts due to the Company on account of the share.
|
7.5 |
The content of this section shall not derogate from any other relief of the Company vis-à-vis a shareholder who fails to pay his debt to the Company on account of his shares.
|
8. |
Transfer of Shares
|
8.1 |
The Company’s shares are transferable.
|
8.2 |
The transfer of shares must be made in writing, and it shall be recorded only if –
|
8.2.1 |
A proper certificate for the transfer of shares, together with the certificates of the share intended for transfer, if such were issued, is delivered to the Company at its registered office. The certificate of transfer shall be signed by
the transferor and by a witness confirming the signature of the transferor. In the event of the transfer of shares that are not fully paid as of the date of transfer, the certificate of transfer shall also be signed by the recipient of the
share and by a witness testifying to the signature of the recipient; or
|
8.2.2 |
A court order for the amendment of the registration shall be delivered to the Company; or
|
8.2.3 |
It shall be proved to the Company that lawful conditions pertain for the transfer of the right to the share.
|
8.3 |
The transfer of shares that have not been fully paid requires the authorization of the Board of Directors, which is entitled to refuse to grant its authorization at its absolute discretion and without stating grounds therefore.
|
8.4 |
The recipient of the transfer shall be considered the shareholder regarding the transferred shares from the moment of the registration of his name in the registry of shareholders.
|
9. |
Changes in Capital
|
9.1 |
The general meeting is entitled to increase the Company’s registered share capital by creating new shares of an existing type or a new type, all as shall be determined in the decision of the general meeting.
|
9.2 |
The general meeting is entitled to nullify registered share capital that has not yet been allocated, provided that there is no commitment, including a conditioned commitment, by the Company to allocate the shares.
|
9.3 |
The general meeting shall be entitled, subject to the provisions of any law:
|
9.3.1 |
To unify and redivide its share capital, or any part thereof, into shares of a nominal value greater than the nominal value of the existing shares.
|
9.3.2 |
To divide, by way of the redivision of any or all of the existing shares, its share capital into shares of a nominal value smaller than the nominal value of the existing shares.
|
9.3.3 |
To reduce its share capital and any reserved fund for the repayment of capital in such manner and on such conditions and with the receipt of such authorization as shall be required by the Companies Law.
|
10. |
Changes in the Rights of Share Types
|
10.1 |
Unless otherwise stated in the conditions of issue of the shares, and subject to the provisions of any law, the rights of any share type may be changed following a decision of the Company’s Board of Directors, and with the authorization
of the general meeting of shareholders of that type, or with the written consent of all the shareholders of that type. The provisions of the Company’s Articles of Association regarding general meetings shall apply, mutatis mutandis, to a general meeting of type shareholders.
|
10.2 |
The rights granted to the holders of shares of a specific type issued with special rights shall not be considered to have been changed by virtue of the creation or issue of additional shares of equal grade, unless otherwise conditioned
in the conditions of issue of the said shares.
|
11. |
General Meetings
|
11.1 |
Company decisions on the following matters shall be taken at the general meeting –
|
11.1.1 |
Changes to the Articles;
|
11.1.2 |
Exercising the authorities of the Board of Directors in the event that the Board of Directors is unable to perform its function;
|
11.1.3 |
Appointment of the auditing accountant of the Company and the cessation of employment thereof;
|
11.1.4 |
Appointment of directors, including external directors;
|
11.1.5 |
Authorization of actions and transactions requiring the authorization of the general meeting in accordance with the provisions of the Companies Law and any other law;
|
11.1.6 |
Increasing and decreasing the registered share capital;
|
11.1.7 |
Merger as defined in the Companies Law.
|
11.2 |
Subject to the provisions of the law, the general meeting is entitled to assume authorities granted to another organ in the Company, including the Board of Directors, for a particular matter or for a given period of time.
|
12. |
Convening of General Meetings
|
12.1 |
General meetings shall be convened at least once a year at such a venue and on such a date as shall be determined by the Board of Directors, and subject to the provisions of the law, but not later than 15 months after the previous
general meeting. These general meetings shall be called “annual meetings.” The remaining meetings of the Company shall be called “extraordinary meetings.”
|
12.2 |
The agenda at the annual meeting shall include discussion of the report of the Board of Directors and financial statements as required by law. The annual meeting shall appoint an auditing accountant; shall appoint the directors in
accordance with these Articles; and shall discuss all other matters to be discussed at the annual meeting of the Company in accordance with these Articles or in accordance with the Companies Law, as well as any other matter as shall be
determined by the Board of Directors.
|
12.3 |
The Board of Directors is entitled to convene an extraordinary meeting in accordance with its decision, and must convene a general meeting if a written request is received from any of the following (hereinafter – “Request to Convene:”)
|
12.3.1 |
Two directors or one-fourth of the incumbent directors; and/or
|
12.3.2 |
One or more shareholders holding at least five percent of the issued capital and at least one percent of the voting rights in the Company; and/or
|
12.3.3 |
One or more shareholders holding at least five percent of the voting rights in the Company.
|
12.4 |
Any Request to Convene must specify the goals for whose purpose the meeting is to be convened, and shall be signed by those requesting the convening and delivered at the Company’s registered office. The request may consist of a number of
documents of identical format, each signed by one or more individuals making the request.
|
12.5 |
A Board of Directors required to convene an extraordinary meeting shall convene such meeting within twenty-one days from the date on which the Request to Convene was submitted thereto, for a date determined in an invitation in accordance
with section 12.6 below and subject to any law.
|
12.6 |
Notification of the members of the Company regarding the convening of a general meeting shall be published or delivered to all the shareholders registered in the registry of shareholders in the Company in accordance with the requirements
of the law. The notification shall include the agenda, the proposed decisions, and arrangements regarding voting in writing.
|
13. |
Discussion at General Meetings
|
13.1 |
The discussion at the general meeting shall be opened only if a legal quorum is present at the time the discussion begins. A legal quorum is the presence of at least two shareholders holding at least 25 percent of the voting rights
(including presence by means of proxy or through a letter of voting) within one half-hour from the time specified for the opening of the meeting.
|
13.2 |
If, at the end of one half-hour from the time specified for the opening of the meeting, no legal quorum is present, the meeting shall be postponed by one week, to the same day, the same hour, and the same venue, or to a later date, if
specified on the invitation to the meeting or in the notification of the meeting (hereinafter – “the Postponed Meeting.”) Notification and invitation regarding a Postponed Meeting postponed for a
period of not more than 21 days shall be made not later than seventy-two hours prior to the Postponed Meeting. Notification of a Postponed Meeting shall be made as stated in section 12.6, mutatis mutandis.
|
13.3 |
The legal quorum for commencing a Postponed Meeting shall be any number of participants.
|
13.4 |
The chairperson of the Board of Directors shall serve as the chairperson of the general meeting. If the chairperson of the Board of Directors is absent from the meeting after 15 minutes from the time specified for the meeting, or if he
refuses to serve as the chairperson of the meeting, the chairperson shall be elected by the general meeting.
|
13.5 |
A general meeting with a legal quorum is entitled to decide on the postponement of the meeting to another date and to such venue as shall be determined and, in this case, notifications and invitations to the Postponed Meeting shall be
made as stated in section 13.2 above.
|
14. |
Voting at a General Meeting
|
14.1 |
A shareholder in the Company shall be entitled to vote at general meetings in person or by means of a proxy or a letter of voting.
|
14.2 |
In any vote, each shareholder shall have a number of votes equivalent to the number of shares in their possession entitling the holder to a vote.
|
14.3 |
A decision at the general meeting shall be taken by an ordinary majority unless another majority is determined in the Companies Law or in these Articles.
|
14.4 |
The declaration by the chairperson of the meeting that a decision has been adopted unanimously or by a given majority, or rejected or not adopted by a given majority, shall constitute prima facie evidence of the content thereof.
|
14.5 |
If the votes at the meeting are equally divided, the chairperson of the meeting shall not have an additional or casting opinion and the decision presented for voting shall be rejected.
|
14.6 |
Subject to any law, the shareholders in the Company are entitled to vote in any matter on the agenda of a general meeting (including type meetings) by means of a letter of voting, provided that the Board of Directors, subject to any law,
has not negated in its decision to convene the general meeting the possibility of voting by means of a letter of voting on that matter.
|
14.7 |
A shareholder is entitled to state the manner of his vote in the letter of voting and to deliver this to the Company up to 48 hours prior to the time of commencement of the meeting. A letter of voting stating the manner of voting of the
shareholder reaching the Company at least 48 hours prior to the time of commencement of the meeting shall be considered tantamount to presence at the meeting, including for the matter of the presence of the legal quorum as stated in section
13.1 above.
|
14.8 |
Appointment of a proxy shall be in writing, signed by the appointer (hereinafter – “Power of Attorney.”) A corporation shall vote by means of its representatives, who shall be appointed in a
document signed properly by the corporation (hereinafter – “Letter of Appointment.”)
|
14.9 |
A vote in accordance with the conditions of a Power of Attorney shall be lawful even if the appointer dies before the voting, or becomes legally incompetent, is liquidated, becomes bankrupt, nullifies the Letter of Appointment, or
transfers the share regarding which it was given, unless written notification is received at the Company’s office prior to the meeting that the shareholder has died, become legally incompetent, been liquidated, become bankrupt, or has
nullified the Letter of Appointment or transferred the shares as stated.
|
14.10 |
The Letter of Appointment and the Power of Attorney, or a copy authorized by an attorney, shall be deposited at the Company’s registered offices at least forty eight (48) hours prior to the time determined for the meeting or for the
Postponed Meeting at which the person mentioned in the document intends to vote in accordance therewith.
|
14.11 |
A shareholder in the Company shall be entitled to vote at the Company’s meetings by means of several proxies appointed thereby, provided that each proxy shall be appointed on account of different sections of the shares held by the said
shareholder. There shall be no impediment to each proxy as stated voting in a different manner in the Company’s meetings.
|
14.12 |
If a shareholder is legally incompetent, he is entitled to vote by means of his trustees, the recipient of his assets, his natural guardian or other legal guardian, and these are entitled to vote in person or by proxy or a Letter of
Voting.
|
14.13 |
When two or more persons are the joint owners of a share, in a vote on any matter the vote of the person whose name is registered first in the registry of shareholders as the owner of that share shall be accepted, whether in person or by
proxy, and he is entitled to deliver Letters of Voting to the Company.
|
15. |
The Board of Directors
|
16. |
Appointment of the Board of Directors and Cessation of Office Thereof
|
16.1 |
The number of directors in the Company shall be determined from time to time by the annual general meeting, provided that this shall not be fewer than 5 and not more than 10 directors, including external directors. The number of external
directors in the Company shall not be less than the number determined in the Companies Law.
|
16.2 |
The directors in the Company shall be elected at an annual meeting and/or an extraordinary meeting, and shall serve in their office for so long as they have not been replaced by the shareholders of the Company at an annual meeting and/or
at an extraordinary meeting, or until they cease to serve in their office in accordance with the provisions of the Articles or any law, whichever is the earlier.
|
16.3 |
In addition to the content of section 16.2 above, the Board of Directors is entitled to appoint a director in place of a director whose position has become vacant and/or by way of an addition to the Board of Directors, subject to the
maximum number of directors on the Board of Directors as stated in section 16.1 above. The appointment of a director by the Board of Directors shall remain valid through the next annual meeting or until the director shall cease to serve in
their office in accordance with the provisions of these Articles or of any law, whichever is the earlier.
|
16.4 |
A director whose period of office has expired may be reelected, with the exception of an external director, who may be reelected for an additional period of office subject to the provisions of the law.
|
16.5 |
The office of a director shall commence on the date of their appointment by the annual meeting and/or the extraordinary meeting and/or the Board of Directors, or on a later date if this date is determined in the decision of appointment
of the annual meeting and/or the extraordinary meeting and/or the Board of Directors.
|
16.6 |
The Board of Directors shall elect one of its members as the chairperson of the Board of Directors. The elected chairperson shall run the meetings of the Board of Directors and shall sign the minutes of the discussion. If no chairperson
is elected, or if the chairperson of the Board of Directors is not present after 15 minutes from the time set for the meeting, the directors present shall choose one of their number to serve as the chairperson at that meeting, and the
chosen member shall run the meeting and sign the minutes of the discussion.
|
16.7 |
The general meeting is entitled to transfer any director from their office prior to the end of the period of their office, inter alia whether the director was appointed thereby in accordance with section 16.2 above or was appointed by
the Board of Directors in accordance with section 16.3 above, provided that the director shall be given a reasonable opportunity to state their case before the general meeting.
|
16.8 |
Any director is entitled, with the agreement of the Board of Directors, to appoint a substitute for themselves (hereinafter – “a Substitute Director,”) provided that a person who is not competent
shall not be appointed to serve as a Substitute Director, nor a person who has been appointed as a Substitute Director for another director and/or a person who is already serving as a director in the Company.
|
16.9 |
The office of a director shall become vacant in any of the following cases:
|
16.9.1 |
He resigns from his office by means of a letter signed in his hand, submitted to the Company and detailing the reasons for his resignation;
|
16.9.2 |
He is removed from his office by the general meeting;
|
16.9.3 |
He is convicted of an offense as stated in Article 232 of the Companies Law;
|
16.9.4 |
In accordance with a court decision as stated in Article 233 of the Companies Law;
|
16.9.5 |
He is declared legally incompetent;
|
16.9.6 |
He is declared bankrupt and, if the director is a corporation – it opted for voluntary liquidation or a liquidation order was issued against it.
|
16.10 |
In the event that the position of a director becomes vacant, the remaining directors shall be entitled to continue to act, provided the number of directors remaining shall not be less than the minimum number of directors as stated above
in section 16.1 above. If the number of directors falls below the above-mentioned minimum number, the remaining directors shall be entitled to act solely in order to fill the place of the director that has become vacant as stated in section
16.3 above, or in order to convene a general meeting of the Company, and pending the convening of the general meeting of the Company as stated they may act to manage the Company’s affairs solely in matters that cannot be delayed.
|
16.11 |
The conditions of office of the members of the Board of Directors shall be authorized in accordance with the provisions of the Companies Law.
|
17. |
Meetings of the Board of Directors
|
17.1 |
The Board of Directors shall convene for a meeting in accordance with the needs of the Company, and at least once every three months.
|
17.2 |
The chairperson of the Board of Directors is entitled to convene the Board at any time. In addition, the Board of Directors shall hold a meeting on such subject as shall be specified in the following cases:
|
17.2.1 |
In accordance with the request of two directors; however, if at the time the Board of Directors comprises five directors or less – in accordance with the request of one director;
|
17.2.2 |
In accordance with the request of one director if, in his request to convene the Board, he states that he has learned of a matter in the Company ostensibly entailing a violation of the law or infringement of proper business practice;
|
17.2.3 |
If a general director has been appointed in the Company or if a notification or report by the general director require an action on the part of the Board of Directors;
|
17.2.4 |
If the auditing accountant has informed the chairperson of the Board of Directors – or, in the event that no chairperson was appointed for the Board of Directors, has informed the Board of Directors – of substantial defects in the
accounting control of the Company.
|
17.3 |
Notification of the meeting of the Board of Directors shall be delivered to all members of the Board at least three days prior to the date of convening of the Board, or with shorter prior notice insofar as the chairperson of the Board
decided that, in the circumstances of the matter, it is vital and reasonable to convene the Board of Directors with notice shorter than three days. Notification shall be delivered to the address of the director as forwarded to the Company
in advance, and shall stipulate the time of the meeting and the venue at which it shall convene, as well as reasonable detail of all subjects on the agenda.
|
17.4 |
The agenda of the meetings of the Board of Directors shall be determined by the chairperson of the Board and shall include: Subjects determined by the chairperson of the Board; subjects deriving from the report of the general director
and/or the auditing accountant; any subject a director of the general director have requested of the chairperson of the Board to include on the agenda, at least two days prior to the convening of the meeting of the Board.
|
17.5 |
The details of the subjects on the agenda as stated in section 17.4 above do not prevent discussion of a subject or subjects not mentioned in the notification of the meeting of the Board of Directors (hereinafter: “a New Subject.”)
|
17.6 |
The legal quorum for the commencement of a meeting of the Board of Directors shall be a majority of the members of the Board of Directors. If, at the end of one half-hour from the time set for the commencement of the meeting, no quorum
is present, the meeting shall be postponed to another date as decided by the chairperson of the Board, or, in his absence, by the directors present at the convened meeting, provided that prior notification of three days shall be given to
all directors regarding the date of the Postponed Meeting. The legal quorum for the opening of a Postponed Meeting shall be any number of participants.
|
17.7 |
The Board of Directors is entitled to hold meetings by use of any means of communication, providing that all the participating directors can hear each other simultaneously.
|
17.8 |
The Board of Directors is entitled to take decisions without actually convening, provided that all the directors entitled to participate in the discussion and to vote on the subject brought for decision agree thereto. If decisions are
made as stated in this section, the chairperson of the Board of Directors shall record minutes of the decisions stating the manner of voting of each director on the subjects brought for decision, as well as the fact that all the directors
agreed to take the decision without convening.
|
18. |
Voting on the Board of Directors
|
18.1 |
Each director shall have one vote when voting on the Board of Directors.
|
18.2 |
Decisions of the Board of Directors shall be taken by a majority vote. The chairperson of the Board of Directors shall not have any additional or casting opinion, and in the event of a tie vote, the decision brought for voting shall be
rejected.
|
19. |
Committees of the Board of Directors
|
19.1 |
The Board of Directors is entitled to establish committees and to appoint members thereto (hereinafter – “the Committees of the Board of Directors.”) If Committees of the Board of Directors are
established, the Board of Directors shall determine, in the conditions of empowerment thereof, whether specific authorities of the Board of Directors shall be delegated to the Committees of the Board of Directors, in such manner that the
decision of the Committee of the Board of Directors shall be considered tantamount to a decision of the Board of Directors, or whether the decision of the Committee of the Board of Directors shall merely constitute a recommendation, subject
to the authorization of the Board of Directors; provided that authorities to make decisions in the matters stated in Article 112 of the Companies Law shall not be delegated to a committee.
|
19.2 |
A person who is not a director shall not serve in a Committee of the Board of Directors to which the Board of Directors has delegated authorities. Persons who are not members of the Board of Directors may serve in a Committee of the
Board of Director whose function is merely to advise or submit recommendations to the Board of Directors.
|
19.3 |
The provisions included in these Articles relating to the meetings of the Board of Directors and voting therein shall apply, mutatis mutandis and subject to the decisions of the Board of
Directors regarding the procedures for the meetings of the committee (if any), to any Committee of the Board of Directors comprising two or more members.
|
20. |
Audit Committee
|
20.1 |
The Board of Directors of the Company shall appoint an audit committee from among its members. The number of members of the audit committee shall be not less than three, and any external director may be a member thereof. The chairperson
of the Board of Directors or any director employed by the Company, or providing it with services on a regular basis, or a controlling shareholder in the Company, or a relative thereof shall not be appointed to the committee.
|
20.2 |
The functions of the audit committee shall be –
|
20.2.1 |
To identify defects in the business management of the Company, inter alia through consultation with the internal auditor of the Company or the auditing accountant, and to propose methods to the Board of Directors for correcting these;
|
20.2.2 |
To decide whether to authorize actions and transactions requiring the authorization of the audit committee in accordance with the Companies Law.
|
21. |
General Director
|
22. |
Exemption, Insurance, and Indemnification
|
22.1 |
enter into a contract for the insurance of the liability, in whole or in part, of any of its “Office Holders” (as defined in the Companies Law) with respect to an obligation imposed on such Office Holder due to an act performed by the
Office Holder in the Office Holder’s capacity as an Office Holder of the Company arising from any of the following:
|
22.2 |
undertake, in advance to indemnify, or may indemnify retroactively, an Office Holder of the Company with respect to any of the following liabilities or expenses that arise from an act performed by the Office Holder by virtue of being an
Office Holder of the Company:
|
23. |
Subject to the provisions of the Law and the Israeli Securities Law, the Company hereby releases, in advance, its Office Holders from liability to the Company for damage that arises from the breach of the
Office Holder’s duty of care to the Company.
|
24. |
The provisions of Articles 22 and 23 are not intended, and shall not be interpreted, to restrict the Company in any manner in respect of the procurement of insurance or in respect of indemnification (i) in
connection with any person who is not an Office Holder, including, without limitation, any employee, agent, consultant or contractor of the Company who is not an Office Holder, or (ii) in connection with any Office Holder to the extent that
such insurance and/ or indemnification is not specifically prohibited under the Companies Law; provided that the procurement of any such insurance or the provision of any such indemnification shall be approved by the Board. Any modification
of Articles 22 through 24, and any amendment to the Companies Law, the Israeli Securities Law or any other applicable law, shall be prospective in effect and shall not affect the Company’s obligation or ability to indemnify an Office Holder
for any act or omission occurring prior to such modification or amendment, unless otherwise provided by the Companies Law, the Israeli Securities Law or such applicable law.
|
25. |
Internal Auditor
|
25.1 |
The Board of Directors of the Company shall appoint an internal auditor in accordance with the proposal of the audit committee. A person who is an interested party in the Company, an office holder therein, or the relative or either of
the above, as well as the auditing accountant or any person on his behalf, shall not serve as an internal auditor in the Company.
|
25.2 |
The Board of Directors shall determine which office holder shall be organizationally accountable for the internal auditor and, in the absence of such determination; this shall be the chairperson of the Board of Directors.
|
25.3 |
The internal audit plan prepared by the auditor shall be submitted to the audit committee for authorization; however, the Board of Directors is permitted to determine that the plan shall be submitted to the Board of Directors for
authorization.
|
26. |
Auditing Accountant
|
26.1 |
The general meeting shall appoint an auditing accountant for the Company. The auditing accountant shall service in his office through the end of the following annual meeting, or for a longer period as determined by the annual meeting,
provided that the period of office shall not be extended beyond the end of the third annual meeting following that at which he was appointed.
|
26.2 |
The fee of the auditing accountant for the auditing operations shall be determined by the Board of Directors. The Board of Directors shall report to the annual meeting on the fee of the auditing accountant.
|
27. |
Signing in the Company’s Name
|
27.1 |
The rights to sign in the Company’s name shall be determined from time to time by the Board of Directors of the Company.
|
27.2 |
The Company’s authorized signatory shall do so together with the Company’s stamp, or alongside its printed name.
|
28. |
Dividend and Benefit Shares
|
28.1 | The decision by the Company to allocate a dividend and/or to allocate benefit shares shall be taken by the Company’s Board of Directors. |
28.2 |
Unless determined otherwise by the Board of Directors, it shall be permitted to pay any dividend by way of check or payment order to be sent by mail in accordance with the registered address of the shareholder or the personal eligible
thereto or, in the case of joint registered owners of the same share, to that shareholder whose name is mentioned first in the registry of shareholders with regard to the joint ownership. Any such check shall be made out to order of the
person to whom it is sent. A receipt from a person whose name, as of the date of declaration of the dividend, is registered in the registry of shareholders as the owner of any share or, in the case of joint owners, of one of the joint
owners, shall serve as authorization regarding all payments made in connection with that share and regarding which the receipt was received.
|
28.3 |
For the purpose of executing any decision in accordance with the provisions of this section, the Board of Directors is entitled to resolve as it sees fit any difficulty that emerges regarding distribution of the dividend and/or the
benefit shares, including determining the value for the purpose of the said division of certain assets, and to determine that payments in cash shall be made to members on the basis of the value so determined; to determine provisions
regarding fractions of shares; or to determine that sums of less than NIS 50 shall not be paid to a shareholder.
|
29. |
Redeemable Securities
|
30. |
Donations
|
31. |
Accounts
|
31.1 |
The Company shall maintain accounts and shall prepare financial statements in accordance with the Securities Law and in accordance with any law.
|
31.2 |
The account ledgers shall be held at the Company’s registered offices or in any other place as the directors shall see fit, and shall always be open for inspection by the directors.
|
32. |
Notifications
|
32.1 |
Subject to any law, a notification or any other document that shall be delivered by the Company, and which it is entitled or required to issue in accordance with the provisions of the Articles and/or the Companies Law, the Securities
Law, or any law, shall be delivered by the Company to any person in one of the following manners as decided by the Company in each individual case: (A) By dispatch by registered mail in a letter addressed in accordance with the registered
address of that shareholder in the registry of shareholders, or in accordance with such address as stated by the shareholder in a letter to the Company as the letter for the delivery of notifications or other documents; or (B) By dispatch
by facsimile in accordance with the number stated by the shareholder as the number for the delivery of facsimile notifications; or (C) By way of publication in two daily newspapers appearing in Israel; or (D) By way of publication in the
distribution site of the Securities Authority and the Tel Aviv Stock Exchange Ltd.
|
32.2 |
Any notification to be made to shareholders shall be made, regarding jointly owned shares, to that person whose name is mentioned first in the registry of shareholders as the holder of that share, and any notification made in this manner
shall be sufficient notification for the holders of that share.
|
32.3 |
Any notification or other document sent in accordance with the provisions of section 30.1 above shall be considered to have reached its destination: (A) Within 3 business days – if sent by registered mail in Israel; or (B) On the first
business day after its dispatch, if delivered by hand or sent by facsimile; or (C) On the date of publication, if published in a newspaper or on the distribution site of the Securities Authority and the Tel Aviv Stock Exchange Ltd.
|
32.4 |
Any record made in an ordinary manner in the company’s registry shall be considered prima facie evidence of dispatch as recorded in that registry.
|
32.5 |
When it is necessary to provide prior notification of a certain number of days, or when notification is valid for a certain period, the date of delivery shall be included in reckoning the number of days or the period.
|
•
|
amendments to our Articles of Association;
|
•
|
appointment or termination of our auditors;
|
•
|
appointment of directors and appointment and dismissal of external directors;
|
•
|
approval of acts and transactions requiring general meeting approval pursuant to the Companies Law;
|
•
|
director compensation, indemnification and change of the principal executive officer;
|
•
|
increases or reductions of our authorized share capital;
|
•
|
a merger; and
|
•
|
the exercise of our Board of Director’s powers by a general meeting, if our Board of Directors is unable to exercise its powers and the exercise of any of its powers is required for our
proper management.
|
•
|
an appointment or removal of directors;
|
•
|
an approval of transactions with office holders, a controlling shareholder or parties related to the foregoing;
|
•
|
an approval of a merger;
|
•
|
authorizing the chairman of the board of directors or his relative to act as the company’s chief executive officer or act with such authority; or authorize the company’s chief executive
officer or his relative to act as the chairman of the board of directors or act with such authority;
|
•
|
any other matter in respect of which there is a provision in the articles of association providing that decisions of the general meeting may also be passed by written ballot; and
|
•
|
other matters which may be prescribed by Israel’s Minister of Justice.
|
•
|
taxes and other governmental charges;
|
•
|
any applicable transfer or registration fees;
|
•
|
certain cable, telex and facsimile transmission charges as provided in the deposit agreement;
|
•
|
any expenses incurred in the conversion of foreign currency;
|
•
|
a fee of $5.00 or less per 100 ADSs (or a portion thereof) for the execution and delivery of ADRs and the surrender of ADRs, including if the deposit agreement terminates;
|
•
|
a fee of $.05 or less per ADS (or portion thereof) for any cash distribution made pursuant to the deposit agreement;
|
•
|
a fee for the distribution of securities pursuant to the deposit agreement;
|
•
|
in addition to any fee charged for a cash distribution, a fee of $.05 or less per ADS (or portion thereof) per annum for depositary services;
|
•
|
a fee for the distribution of proceeds of rights that the Depositary sells pursuant to the deposit agreement; and
|
•
|
any other charges payable by the Depositary, any of the Depositary’s agents, or the agents of the Depositary’s agents in connection with the servicing of ordinary shares or other Deposited
Securities.
|
|
Modi'in Technology Park
2 HaMa'ayan Street
Modi'in 7177871, Israel
Phone: 972-8-642-9100
Fax: 972-8-642-9101
web: www.BioLineRx.com
|
|
Very truly yours,
BioLineRx Ltd.
By: Mali Zeevi
Title: Chief Financial Officer
|
Accepted and agreed as of the date first written above:
/s/ Philip Serlin
Philip Serlin |
|
Modi'in Technology Park
2 HaMa'ayan Street
Modi'in 7177871, Israel
Phone: 972-8-642-9100
Fax: 972-8-642-9101
web: www.BioLineRx.com
|
|
Very truly yours,
BioLineRx Ltd.
/s/ Philip Serlin
By: Philip Serlin
Title: Chief Executive Officer
|
Accepted and agreed as of the date first written above:
/s/ Mali Zeevi
Mali Zeevi |
|
Modi'in Technology Park
2 HaMa'ayan Street
Modi'in 7177871, Israel
Phone: 972-8-642-9100
Fax: 972-8-642-9101
web: www.BioLineRx.com
|
|
Very truly yours,
BioLineRx Ltd.
/s/ Philip Serlin
By: Philip Serlin
Title: Chief Executive Officer
|
Accepted and agreed as of the date first written above:
/s/ Abi Vainstein
Abi Vainstein |
|
Modi'in Technology Park
2 HaMa'ayan Street
Modi'in 7177871, Israel
Phone: 972-8-642-9100
Fax: 972-8-642-9101
web: www.BioLineRx.com
|
|
Very truly yours,
BioLineRx Ltd.
/s/ Philip Serlin
By: Philip Serlin
Title: Chief Executive Officer
|
Accepted and agreed as of the date first written above:
/s/ Ella Sorani
Ella Sorani |
Name of Subsidiary
|
|
Jurisdiction of
Incorporation |
|
|
|
Agalimmune Ltd.
|
|
England and Wales
|
|
1.
|
I have reviewed this annual report on Form 20-F of BioLineRx Ltd.;
|
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by this report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of
the company as of, and for, the periods presented in this report;
|
|
4.
|
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
|
|
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its
consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
|
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and
|
|
|
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to
materially affect, the company’s internal control over financial reporting; and
|
|
5.
|
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s
board of directors (or persons performing the equivalent functions):
|
|
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record,
process, summarize and report financial information; and
|
|
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
|
|
1.
|
I have reviewed this annual report on Form 20-F of BioLineRx Ltd.;
|
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by this report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of
the company as of, and for, the periods presented in this report;
|
|
4.
|
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
|
|
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its
consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
|
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and
|
|
|
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to
materially affect, the company’s internal control over financial reporting; and
|
|
5.
|
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s
board of directors (or persons performing the equivalent functions):
|
|
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record,
process, summarize and report financial information; and
|
|
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
|
Tel-Aviv, Israel
February 23, 2021
|
/s/ Kesselman & Kesselman
Kesselman & Kesselman
Certified Public Accountants (Isr.) A member firm of PricewaterhouseCoopers International Limited |